- OPPORTUNITIES FOR COMMENT / GUIDANCES
- PRODUCT APPROVALS & CLEARANCES
- PRODUCT SAFETY
- UPCOMING MEETINGS
Talking Translational Science
Read the transcript or listen to the podcast from Director's Corner, a series featuring Dr. Janet Woodcock, the director of FDA's Center for Drug Evaluation and Research. Dr. Woodcock delivers an overview of translational science and how the outcomes from this type of research can help speed the development and review of innovative new therapies. More information
Protecting Trade in Safe Food is a Global Concern
Protecting consumers from contaminated foods is a global concern—as well as a key FDA priority. This was clear to us when we attended a World Trade Organization (WTO) conference in Geneva earlier this spring to provide outreach on FDA’s new food safety regulations.
This was the 65th meeting of the WTO’s Committee for Sanitary and Phytosanitary Measures (SPS), an important body that provides a forum for the discussion of food safety and animal and plant health issues that affect the international food trade. While enhancing free trade is WTO’s focus, members understand the importance of facilitating trade in safe food products. More information
3D Printing of Medical Devices
3D printing, also known as additive manufacturing, is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or an MRI image.
The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical devices and other products, including food, household items, and automotive parts. More information
Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition
This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods. The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition and labeling of medical foods and updates some of the prior responses. More information
Use of Electronic Health Record Data in Clinical Investigations; Draft Guidance for Industry
The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance aims to facilitate use of electronic health record (EHR) data in clinical investigations and to promote the interoperability of EHRs and electronic systems supporting the clinical investigation. More information
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers
FDA is issuing this draft guidance to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance characteristics of Infectious Disease Next Generation Sequencing Based Diagnostic Device for Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers (hereafter referred to as “Infectious Disease NGS Dx devices”). Infectious Disease NGS Dx devices are for use as aids in the diagnosis (identification) of microbial infection and in selecting appropriate therapies. More information
Need Safety Information?
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Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections
FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system. More information
MedWatch Drug Safety Labeling Changes- April 2016
Includes 29 products with revisions to Prescribing Information. More information
BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries
FDA is informing health care professionals that a counterfeit version of the FDA approved cancer drug, BiCNU (carmustine for injection) 100 mg, has been detected in some foreign countries. There is no indication at this time that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU. More information
SOS Telecom Products: Recall - Undeclared Drug Ingredient
SOS Telecom, Inc. is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil. Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making these products tainted dietary supplements and unapproved drugs. Sildenafil is not listed on the product labels. More information
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.
Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation Workshop (May 19)
FDA will hold a public workshop titled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation”. Modeling and simulation tools help with developing bioequivalence and regulatory evaluation for oral drug products. More information
FY 2016 Regulatory Science Initiatives Part 15 Public Meeting (May 20)
FDA will hold a public meeting that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. More information
Circulatory System Devices Panel of the Medical Devices Advisory Committee (May 24)
The committee will discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical’s AMPLATZER Patent Foramen Ovale (PFO) Occluder. The AMPLATZER PFO Occluder is a percutaneously delivered permanent cardiac implant for PFO closure. The device is indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. More information
Endocrinologic and Metabolic Drugs Advisory Committee (May 25)
The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus.. More information
Circulatory System Devices Panel of the Medical Devices Advisory Committee (Jun 2-3)
The committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. More information
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (Jun 7-8)
The committees will be asked to discuss two new drug applications The committees will be asked to discuss whether the data submitted by the Applicants are sufficient to support labeling of the product with the properties expected to deter abuse. More information
Antimicrobial Drugs Advisory Committee (Jun 9)
The committee will discuss biologics license application (BLA) 761046, bezlotoxumab (MK-6072) injection, submitted by Merck Sharpe & Dohme Corp., for the proposed indication of prevention of Clostridium difficile infection recurrence. More information
Over-the-Counter Monograph User Fees: Public Meeting (Jun 10)
FDA announced a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user fee program would provide funding to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. FDA invites public comment on a potential OTC monograph user fee program and also invites suggestions regarding the features such a user fee program should include. More information
FDA-AACR: Oncology Dose Finding Workshop (Jun 13)
FDA, in co-sponsorship with the American Association for Cancer Research (AACR), is announcing a public workshop entitled “Oncology Dose Finding Workshop.” More information
For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch
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 email@example.com. 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
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
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 is the official blog from FDA's senior leadership and staff.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