November 1, 2017
ANNOUNCEMENTS
FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections
has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. More information
Statement from FDA Commissioner Scott Gottlieb, M.D., on new strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal
One of my highest priorities as the Commissioner of the FDA is to take whatever steps we can to reduce the scope and human tragedy created by the epidemic of addiction to opioids. At the FDA, we’re especially focused on helping more patients struggling with current addiction receive appropriate care with proven treatments and reducing new cases of addiction. More information
Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease
We’ve long recognized that some foods and nutrients can help reduce the risk of certain diseases or conditions. Since 1990, the FDA has been responsible for evaluating health claims on packaged foods to ensure that they are rooted in strong science. To date, we have authorized 12 such health claims, such as the effect of calcium and vitamin D in helping to lower the risk of osteoporosis or certain fruits and vegetables to lower the risk of cancer. More information
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis
The Trump Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction. We thank President Trump for his leadership in further empowering public and private parties around the country to do everything possible to more forcefully address this complex public health crisis. We are committed to taking additional steps under the new declaration of a public health emergency to more forcefully confront this immense national tragedy. More information
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives
Chairman Walden and Ranking Member Pallone, thank you for the opportunity to testify today before the full committee. The epidemic of opioid addiction that’s devastating our nation is the biggest crisis facing public health officials, FDA included.
As this crisis grew, many of us didn’t recognize the consequence of this threat. We missed opportunities to stem its spread. So we find ourselves at a tragic crossroad. We have a crisis of such massive proportion that the actions we need to take are going to be hard.
We’ll need to touch clinical practice in ways that may make certain parties uncomfortable. This may include such steps as restrictions on prescribing, or mandatory education on providers. Long ago, we ran out of straightforward options.More information
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation. More information
Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico
During the weeks since Hurricanes Irma and Maria devastated the infrastructure of Puerto Rico, the FDA has joined federal and local agencies in the effort to help the people of Puerto Rico recover and begin to rebuild the island. Among the challenges the FDA has addressed is the potential for shortages of critical medical products. The FDA has been monitoring more than 40 drug products and working closely with dozens of pharmaceutical and medical device companies to help these important facilities get back online; enabling employees to return to work and manufacturers to ramp up production of medical products used by all Americans. More information
PRODUCT APPROVALS & CLEARANCES
FDA Approves New Indication for Soliris (Eculizumab) As Treatment for Myasthenia Gravis
On October 23, 2017, FDA approved a new indication for Soliris (eculizumab), the first new treatment in many years for Myasthenia Gravis, a rare and chronic neuromuscular disorder. It is the first monoclonal antibody approved for use in patients with Myasthenia Gravis who are anti-acetylcholine receptor antibody-positive. Soliris can lower the ability of the immune system to fight infections and therefore increases the chance of getting serious and life-threatening meningococcal infections. For more information, please read the medication guide, the Full Prescribing Label, or theapproval letter sent to the manufacturer.
FDA approves new treatment for adults with mantle cell lymphoma
granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.” More information
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
PRODUCT SAFETY
MedWatch, The FDA Safety Information and Adverse Event Reporting Program
For important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch.
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers FDA Investigating Increased Rate of Major Adverse Cardiac Events
The FDA issued an update to the March 18, 2017 letter to health care providers to inform the health care community that interim study results through three years from the pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and BVS scaffold thrombosis in patients receiving the Absorb GT1 Bioresorbable Vascular Scaffold (BVS), when compared to patients treated with the approved metallic XIENCE drug-eluting stent..More information
Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market
Octapharma USA Inc. is initiating a voluntary market withdrawal of octagam 10% [Immune Globulin Intravenous (human)] 10% Liquid Preparation] that is labeled with lot numbers K724B8541 & K725A8541. Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at FDA, the most prudent course of action is to suspend further administration of octagam 10% from these particular production lots. More information
FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues
FDA issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results. More information
Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination
SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. The is a potential for the products to contain microbial contamination. See the recall notice for a full list of products. More information
UPCOMING MEETINGS
FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees. Click on "more information" for details about each meeting.
Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.
NOVEMBER
Geriatric Oncology by FDA and the American Society of Clinical Oncology (Nov 6)
FDA and ASCO will hold a workshop on improving the evidence base for treating the geriatric oncology population. The representation of older adults in National Cancer Institute (NCI) and FDA registration trials has remained low, and there is limited safety and efficacy information reported on older adults. More information
National Center for Toxicological Research Science (Nov 6-7)
The SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Systems Biology Subcommittee and the Subcommittee Site Visit Report and a response to this review. There will be updates from the NCTR Research Divisions and a public comment session. More information
Vaccines and Related Biological Products Advisory Committee Meeting Announcement (Nov 7)
The committee will meet in an open session to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations. More information
Immune Globulin Potency in the 21st Century; Public Workshop (Nov 8-9)
The FDA is conducting a public workshop entitled “Immune Globulin Potency in the 21st Century.” The purpose of the public workshop is to discuss new challenges for Industry to meet U.S. potency requirements for Immune Globulin (IG) products and to identify measures to address these challenges. The workshop has been planned in partnership with the Immune Deficiency Foundation (IDF) and the Plasma Protein Therapeutics Association (PPTA). The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies. More information
Partners in Progress: Cancer Patient Advocates and FDA (Nov 13)
The FDA Oncology Center of Excellence announces the first annual educational workshop for new cancer patient advocates entitled, "Partners in Progress: Cancer Patient Advocates and FDA." The objectives of this meeting are to provide basic training on the role of the FDA and cancer patient advocates in oncology product development. This broad introduction to FDA regulatory aspects of oncology product development will be most relevant to attendees with limited knowledge and experience in cancer product development and patient advocacy. More information
Devices Referencing Drugs (Nov 16)
FDA is holding a public hearing on a potential approach for certain device sponsors to seek marketing authorization for a device labeled for use with a drug that is already approved and on the market, when the drug sponsor does not wish to pursue the new use. Called devices referencing drugs (DRDs), these products have the potential to advance public health by offering new uses with approved, marketed drugs that might not otherwise be available. More information
Antimicrobial (Nov 16)
The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens. More information
Defining Disease Recurrence and Harmonizing Conduct in Adjuvant Bladder and Kidney Cancer Trials (Nov 28)
The FDA, NCI, and Socieety of Surgical Oncology (SUO) have agreed to joint development of a public workshop that may improve the conduct of adjuvant clinical trials in bladder cancer and kidney cancer by harmonizing definitions and management of disease recurrence. Currently, no standard definition of disease recurrence is used in these adjuvant trials. Standard practices would generate consistency and facilitate interpretation of trial results. This joint venture will enable the oncology community to combine its resources and knowledge to optimize clinical trial utility and efficiency to better serve our patients. More information
DECEMBER
Packaging, Storage, and Disposal Options to Enhance Opioid Safety-Exploring the Path Forward (Dec 11-12)
The purpose of the public workshop is to host a scientific discussion with expert panel members and interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems. More information
RESOURCES
For more important safety information on human drug and devices or to report a problem to FDA, please visitMedWatch, The FDA Safety Information and Adverse Event Reporting Program
Opportunities for Comment
The FederalRegister.gov website was developed to make it easier for citizens and communities to understand the regulatory process and to participate in Government decision-making. The Office of the Federal Register of the National Archives and Records Administration and the U.S. Government Publishing Office jointly administer the FederalRegister.gov website. Search for opportunities to comment on FDA Public Notices.
MedWatchLearn - Practice Reporting to FDA!
This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA. More information
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov. Comunicaciones de la FDA
FDA Expert Commentary and Interview Series on Medscape
As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices. More information
Cardiovascular and Endocrine Liaison Program
The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information
Medical Product Safety Network (Medsun)
Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety. More information
FDA Basics
Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information
FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff. More information
November 1, 2017
ANNOUNCEMENTS
FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections
has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. More information
Statement from FDA Commissioner Scott Gottlieb, M.D., on new strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal
One of my highest priorities as the Commissioner of the FDA is to take whatever steps we can to reduce the scope and human tragedy created by the epidemic of addiction to opioids. At the FDA, we’re especially focused on helping more patients struggling with current addiction receive appropriate care with proven treatments and reducing new cases of addiction. More information
Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease
We’ve long recognized that some foods and nutrients can help reduce the risk of certain diseases or conditions. Since 1990, the FDA has been responsible for evaluating health claims on packaged foods to ensure that they are rooted in strong science. To date, we have authorized 12 such health claims, such as the effect of calcium and vitamin D in helping to lower the risk of osteoporosis or certain fruits and vegetables to lower the risk of cancer. More information
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis
The Trump Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction. We thank President Trump for his leadership in further empowering public and private parties around the country to do everything possible to more forcefully address this complex public health crisis. We are committed to taking additional steps under the new declaration of a public health emergency to more forcefully confront this immense national tragedy. More information
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives
Chairman Walden and Ranking Member Pallone, thank you for the opportunity to testify today before the full committee. The epidemic of opioid addiction that’s devastating our nation is the biggest crisis facing public health officials, FDA included.
As this crisis grew, many of us didn’t recognize the consequence of this threat. We missed opportunities to stem its spread. So we find ourselves at a tragic crossroad. We have a crisis of such massive proportion that the actions we need to take are going to be hard.
We’ll need to touch clinical practice in ways that may make certain parties uncomfortable. This may include such steps as restrictions on prescribing, or mandatory education on providers. Long ago, we ran out of straightforward options.More information
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation. More information
Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico
During the weeks since Hurricanes Irma and Maria devastated the infrastructure of Puerto Rico, the FDA has joined federal and local agencies in the effort to help the people of Puerto Rico recover and begin to rebuild the island. Among the challenges the FDA has addressed is the potential for shortages of critical medical products. The FDA has been monitoring more than 40 drug products and working closely with dozens of pharmaceutical and medical device companies to help these important facilities get back online; enabling employees to return to work and manufacturers to ramp up production of medical products used by all Americans. More information
PRODUCT APPROVALS & CLEARANCES
FDA Approves New Indication for Soliris (Eculizumab) As Treatment for Myasthenia Gravis
On October 23, 2017, FDA approved a new indication for Soliris (eculizumab), the first new treatment in many years for Myasthenia Gravis, a rare and chronic neuromuscular disorder. It is the first monoclonal antibody approved for use in patients with Myasthenia Gravis who are anti-acetylcholine receptor antibody-positive. Soliris can lower the ability of the immune system to fight infections and therefore increases the chance of getting serious and life-threatening meningococcal infections. For more information, please read the medication guide, the Full Prescribing Label, or theapproval letter sent to the manufacturer.
FDA approves new treatment for adults with mantle cell lymphoma
granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.” More information
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
PRODUCT SAFETY
MedWatch, The FDA Safety Information and Adverse Event Reporting Program
For important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch.
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers FDA Investigating Increased Rate of Major Adverse Cardiac Events
The FDA issued an update to the March 18, 2017 letter to health care providers to inform the health care community that interim study results through three years from the pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and BVS scaffold thrombosis in patients receiving the Absorb GT1 Bioresorbable Vascular Scaffold (BVS), when compared to patients treated with the approved metallic XIENCE drug-eluting stent..More information
Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market
Octapharma USA Inc. is initiating a voluntary market withdrawal of octagam 10% [Immune Globulin Intravenous (human)] 10% Liquid Preparation] that is labeled with lot numbers K724B8541 & K725A8541. Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at FDA, the most prudent course of action is to suspend further administration of octagam 10% from these particular production lots. More information
FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues
FDA issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results. More information
Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination
SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. The is a potential for the products to contain microbial contamination. See the recall notice for a full list of products. More information
UPCOMING MEETINGS
FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees. Click on "more information" for details about each meeting.
Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.
NOVEMBER
Geriatric Oncology by FDA and the American Society of Clinical Oncology (Nov 6)
FDA and ASCO will hold a workshop on improving the evidence base for treating the geriatric oncology population. The representation of older adults in National Cancer Institute (NCI) and FDA registration trials has remained low, and there is limited safety and efficacy information reported on older adults. More information
National Center for Toxicological Research Science (Nov 6-7)
The SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Systems Biology Subcommittee and the Subcommittee Site Visit Report and a response to this review. There will be updates from the NCTR Research Divisions and a public comment session. More information
Vaccines and Related Biological Products Advisory Committee Meeting Announcement (Nov 7)
The committee will meet in an open session to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations. More information
Immune Globulin Potency in the 21st Century; Public Workshop (Nov 8-9)
The FDA is conducting a public workshop entitled “Immune Globulin Potency in the 21st Century.” The purpose of the public workshop is to discuss new challenges for Industry to meet U.S. potency requirements for Immune Globulin (IG) products and to identify measures to address these challenges. The workshop has been planned in partnership with the Immune Deficiency Foundation (IDF) and the Plasma Protein Therapeutics Association (PPTA). The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies. More information
Partners in Progress: Cancer Patient Advocates and FDA (Nov 13)
The FDA Oncology Center of Excellence announces the first annual educational workshop for new cancer patient advocates entitled, "Partners in Progress: Cancer Patient Advocates and FDA." The objectives of this meeting are to provide basic training on the role of the FDA and cancer patient advocates in oncology product development. This broad introduction to FDA regulatory aspects of oncology product development will be most relevant to attendees with limited knowledge and experience in cancer product development and patient advocacy. More information
Devices Referencing Drugs (Nov 16)
FDA is holding a public hearing on a potential approach for certain device sponsors to seek marketing authorization for a device labeled for use with a drug that is already approved and on the market, when the drug sponsor does not wish to pursue the new use. Called devices referencing drugs (DRDs), these products have the potential to advance public health by offering new uses with approved, marketed drugs that might not otherwise be available. More information
Antimicrobial (Nov 16)
The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens. More information
Defining Disease Recurrence and Harmonizing Conduct in Adjuvant Bladder and Kidney Cancer Trials (Nov 28)
The FDA, NCI, and Socieety of Surgical Oncology (SUO) have agreed to joint development of a public workshop that may improve the conduct of adjuvant clinical trials in bladder cancer and kidney cancer by harmonizing definitions and management of disease recurrence. Currently, no standard definition of disease recurrence is used in these adjuvant trials. Standard practices would generate consistency and facilitate interpretation of trial results. This joint venture will enable the oncology community to combine its resources and knowledge to optimize clinical trial utility and efficiency to better serve our patients. More information
DECEMBER
Packaging, Storage, and Disposal Options to Enhance Opioid Safety-Exploring the Path Forward (Dec 11-12)
The purpose of the public workshop is to host a scientific discussion with expert panel members and interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems. More information
RESOURCES
For more important safety information on human drug and devices or to report a problem to FDA, please visitMedWatch, The FDA Safety Information and Adverse Event Reporting Program
Opportunities for Comment
The FederalRegister.gov website was developed to make it easier for citizens and communities to understand the regulatory process and to participate in Government decision-making. The Office of the Federal Register of the National Archives and Records Administration and the U.S. Government Publishing Office jointly administer the FederalRegister.gov website. Search for opportunities to comment on FDA Public Notices.
MedWatchLearn - Practice Reporting to FDA!
This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA. More information
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov. Comunicaciones de la FDA
FDA Expert Commentary and Interview Series on Medscape
As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices. More information
Cardiovascular and Endocrine Liaison Program
The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information
Medical Product Safety Network (Medsun)
Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety. More information
FDA Basics
Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information
FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff. More information
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