- ANNOUNCEMENTS
- OPPORTUNITIES FOR COMMENT / GUIDANCES
- PRODUCT APPROVALS & CLEARANCES
- PRODUCT SAFETY
- UPCOMING MEETINGS
- RESOURCES
ANNOUNCEMENTS
 Fresh Empire: FDA launches an Innovative Tobacco Public Health Education Campaign
Tobacco use can damage the body and lead to a range of diseases and conditions, such as cancer, heart disease, and respiratory illness. Unfortunately, the health burdens of tobacco use can disproportionately affect some minority communities. More information
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FDA alerts prescribers and pharmacists to continue clozapine prescribing and dispensing if they encounter online Clozapine REMS certification issues
The FDA is aware that in recent days, technical difficulties with the new Clozapine REMS websitehave prevented some pharmacies and prescribers from completing their required online Clozapine REMS certification. This has resulted in patient access issues in some cases. The clozapine manufacturers, who are the REMS program administrators, have notified FDA that these technical issues have been resolved as of October 16, 2015. If prescribers and pharmacists continue to experience any issues, they should use clinical judgment and consider the best interests of the patient. Continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved. More information
OPPORTUNITIES FOR COMMENT / GUIDANCES
 General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet
FDA is issuing a proposed rule to put forward safety requirements for pediatric medical cribs and bassinets used in traditional health care, home, and child care settings to address potential risks associated with these devices. The rule proposes new safety requirements for pediatric medical cribs and bassinets to lower the chance of harm to infants and children. The FDA currently has no mandatory standards for issues such as the width of the slats in medical cribs (i.e., spacing between each slat) and mattress flammability. The FDA believes that requirements are necessary to ensure medical cribs and bassinets are safe to use.Submit either electronic or written comments by December 7, 2015.
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Prescription Drug User Fee Act; Reopening of Comment Period
FDA is reopening until April 29, 2016, the comment period for the notice of public meeting that appeared in the Federal Register of May 13, 2015 (80 FR 27323). In the notice of public meeting.
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
FDA is announcing the availability of a final guidance for industry entitled “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for these outsourcing facilities. Submit either electronic or written comments on Agency guidances at any time.
PRODUCT APPROVALS & CLEARANCES
 | FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa
FDA granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
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FDA approves first Factor X concentrate to treat patients with rare hereditary bleeding disorder
FDA approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency. More information
FDA expands approved use of Opdivo in advanced lung cancer
FDA approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed
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PRODUCT SAFETY
Need Safety Information?
For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.
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 | Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength
On October 9, 2015, Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. More information
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Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance
Downing Labs, LLC is voluntarily recalling all lots of sterile products compounded and packaged by Downing Labs and that remain within expiry due to concerns over sterility assurance. The products were distributed nationwide and in the UK to patients and providers between April 20, 2015 and September 15, 2015. If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. More information
Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated With Nontuberculous Mycobacteria Infections
Through analysis of adverse event reports, the medical literature, and information from national and international public health agencies, FDA is aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.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.
Arthritis Advisory Committee Meeting (October 23)
The committee will discuss new drug application (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor. More information
Patient and Consumer Stakeholder Meetings - MDUFA Reauthorization (October 26)
FDA will host meetings to discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During these meetings, representatives from patient and consumer advocacy groups can discuss their views on reauthorization and provide suggestions for improving the program. The statutory authority for MDUFA expires September 30, 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. More information
In Vitro Diagnostic Testing for Direct Oral Anticoagulants, Public Workshop (October 26)
The objective of the workshop is to discuss analytical performance requirements for the diagnostic assessment of direct oral anticoagulants (DOACs), and the clinical circumstances under which patients receiving these agents would require testing. Specifically, this workshop aims to 1) evaluate the impact of DOACs on traditional coagulation testing results; 2) identify clinical circumstances where testing of DOACs anticoagulant activity or concentration would be relevant; 3) discuss clinically meaningful interpretation of coagulation testing results for patients on DOACs; and 4) review the regulatory requirements for granting clearance for in vitro diagnostic devices intended for coagulation testing in patients treated with DOACs.
Pharmacy Compounding Advisory Committee (October 27)
FDA will discuss with the committee drugs proposed for inclusion on the withdrawn or removed list pursuant to sections 503A and 503B of the FD&C Act and on the section 503A bulk drug substances list.
Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement (November 3)
The committee will discuss new drug application (NDA) 207959, enclomiphene citrate 12.5 milligram (mg) and 25 mg capsules, submitted by Repros Therapeutics, Inc., for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/milliliter (ml)), younger than 60 years of age with a Body Mass Index (BMI) over 25 kilograms (kg)/meters squared (m2).
Joint Meeting of the Antimicrobial Drugs Advisory Committee (Formerly Known as the Anti-Infective Drugs Advisory Committee) and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (November 5)
The committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.
Drug Interactions with Hormonal Contraceptives; Public Health and Drug Development Implications; Public Meeting (November 9)
FDA is announcing a public meeting entitled “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications” and an opportunity for public comment on the topic of drug interactions with hormonal contraceptives (HCs).
Scientific Workshop on Labeling “Lower” Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy (VVA) (November 10)
This scientific workshop will provide an opportunity for FDA to obtain input from experts on several topics related to the product label of lower dose estrogen-alone products approved solely for the treatment of moderate to severe symptoms of VVA due to menopause.
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting (November 24)
The committee will discuss new drug application (NDA) 206031, drisapersen solution for injection, sponsored by BioMarin Pharmaceutical Inc., for the treatment of patients with Duchenne muscular dystrophy with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping as determined by genetic testing. More information
RESOURCES
For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch
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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
 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
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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.
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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.
FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff.More information
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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.
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