miércoles, 15 de noviembre de 2017

FDA Updates for Health Professionals - November 15, 2017

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ANNOUNCEMENTS

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom
The FDA is concerned about harmful unapproved products that have been crossing our borders in increasing numbers. The agency has a public health obligation to act when we see people being harmed by unapproved products passed off as treatments and cures for serious conditions. More information

Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
To manage the risks associated with drugs, the FDA employs a range of tools. For drugs that are associated with serious risks, the FDA can require drug makers to develop a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. REMS can contain a variety of tools – such as a Medication Guide or patient package insert with information specifically written for patients, a communication plan, and various “Elements to Ensure Safe Use” (ETASU). These elements may include requirements for prescriber training or patient counseling. These safety strategies are critical tools for the FDA to protect patient safety, which is why we want to help manufacturers apply these programs correctly, consistently, and efficiently. More information

Statement from FDA Commissioner Scott Gottlieb, M.D., on a practical approach to ensuring timely implementation of FDA’s menu labeling rule
As someone who enjoys eating out with my family and picking up the occasional take-out meal, I – like many Americans – want to know what’s in the food I eat. As FDA Commissioner, I also know that more people are eating meals away from home, and our diets are increasingly comprised of foods we get from restaurants or take-out meals. FDA is committed to leveraging nutrition to enhance health and reduce disease, and the agency soon will be announcing a broader policy effort in this area. One important step is ensuring consumers have access to reliable and actionable information about the foods they eat so that they can make more informed choices about their diets and health for themselves and their families. More information
 

 


PRODUCT APPROVALS & CLEARANCES

FDA approves pill with sensor that digitally tracks if patients have ingested their medication
The FDA approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. More information

FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer
The FDA expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD. 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


FDA warns about illegal use of injectable silicone for body contouring and associated health risks
The FDA issued a safety communication to warn consumers and health care practitioners about the serious injuries and disfigurement that can result from using injectable silicone or products being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of their buttocks, breasts and other body parts. More information

FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer
The FDA issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective. The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. More information


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.
 


DRUG SHORTAGES

Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:

Drug Shortages Resolved by Manufacturers During the past 2 Weeks:
Drug Shortages Discontinued by Manufacturers During the past 2 Weeks:
FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients.
More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages



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
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


Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (Dec. 7)
The committee will discuss appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The committee will also discuss whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions. More information

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


Medical Gas Regulation Public Workshop (Dec. 15)
The FDA is holding these workshops to provide an opportunity for medical gas manufacturers and any other interested members of the public to provide input on potential areas of Federal drug regulation that should be revised with respect to medical gases. More information

Public Workshop on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input (Dec. 18)
The FDA is conducting a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA to inform regulatory decision-making may use. The workshop will focus on topics related to approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act and to meet a performance goal included in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VI). 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.govComunicaciones 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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