FDA Policy/General
Federal Register Notice: FDA has determined that Endo Pharmaceuticals’ Parkinson’s drug Symmetrel (amantadine hydrochloride), syrup, 50 milligrams/5 milliliters (50 mg/5 mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that the agency can allow ANDA approvals for products that reference Symmetrel
FDA Policy/General
In his final days as FDA commissioner, Robert Califf announced 1/18 that the agency is evaluating changes to the advisory committee (AC) process. He acknowledged that advisory committees have “been the subject of ongoing discussions concerning their impartiality, their transparency, and how they affect decisions made about FDA-regulated
FDA Policy/General
Mintz Levin attorneys Joanna Hawana and Bethany Hills says changes are likely to FDA in 2017, both arising from the election of Donald Trump and from approval of the 21st Century Cures Act and “must-pass” user fee legislation. Writing in an online blog post, the two say that while
FDA Policy/General
FDA’s Center for Veterinary Medicine (CVM) 1/18 announced an alert to pet owners, veterinarians, health care providers and pharmacists that “pets are at risk of illness and death when exposed to the topical cancer medication fluorouracil cream USP 5% intended for use in people.” It said the agency
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Horizon Pharmaceuticals Riviera Beach, FL (12/23/2016): FDA inspected the firm in 2015 and documented significant GMP violations for finished pharmaceuticals. The letter says the firm failed to
FDA Policy/General
One of president-elect Donald Trump’s candidates (see earlier story) for leading FDA has deleted his Twitter posts, presumably to block the public from learning his thoughts and criticisms about the agency and other areas. Entrepreneur Balaji Srinivasan, who founded a genomic testing company and works at the venture
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” The document provides recommendations that focus on the analysis of the proposed user interface for any proposed generic drug-device
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Referencing Approved Drug Products in ANDA Submissions.” The document provides information to potential applicants on how to identify a reference listed drug, reference standard, and the basis of submission in an ANDA submission. To view the guidance, click here.
FDA Policy/General
Forward Pharma A/S has entered into a binding agreement with two wholly owned subsidiaries of Biogen and certain other parties. Under the agreement, Biogen will pay Forward $1.25 billion and it will be obligated to pay Forward royalties of up to 10-20% of net sales of Biogen
FDA Policy/General
The Alliance for a Stronger FDA foresees funding battles for the agency as the incoming Trump Administration looks at deficit reductions through cuts in discretionary spending. In its weekly update (reprinted below), the Alliance predicts that discretionary spending (which makes up a large portion of FDA’s budget) is likely
FDA Policy/General
Federal Register Notice: FDA has established a docket to receive comments about policy issues that may be considered by the FDA Combination Product Policy Council. The comments are intended to help the agency identify and address combination product policy issues that need clarification through guidance, notice and comment procedures, or
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension related to its use of rapid response surveys of community based health care professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.), other health care professionals, patients, consumers,
FDA Policy/General
FDA has posted a draft guidance on “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” The document provides recommendations that focus on the analysis of the proposed user interface for any proposed generic drug-device combination product when compared
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Emergency Use Authorization of Medical Products and Related Authorities.” The document outlines FDA’s current thinking on the authorization of the emergency use of certain medical products under sections of the Federal Food, Drug, and Cosmetic Act as amended by
FDA Policy/General
President-elect Donald Trump’s pick to serve as HHS secretary, House Budget Committee chair Tom Price (R-GA) (see earlier story), has agreed to divest stock ownership in over 40 companies if his appointment is confirmed by the Senate. One potential divesture involves a tiny Australian biotech, Innate Immunotherapeutics,
FDA Policy/General
FDA Webview’s newsroom will be closed Monday (1/16) in observance of Martin Luther King day. Nightly emails will resume 1/17.
FDA Policy/General
Senate HELP Committee chairman Lamar Alexander (R-TN) says Senate confirmation of HHS secretary-designate Tom Price may not come until mid-February, meaning that introduction of a replacement for the Affordable Care Act likely would not come until the beginning of March. Roll Call reports that Alexander made the
FDA Policy/General
President-elect Donald Trump 1/12 reportedly met with two Silicon Valley associates of billionaire tech investor Peter Thiel (see earlier story) for potential posts at FDA, according to The Hill. Trump interviewed Jim O’Neil, a managing director of one of Theil’s venture capital firms, who is high
FDA Policy/General
Federal Register Final Order: FDA has reclassified antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from Class 1 into Class 2 with special controls and into a new device classification regulation.
FDA Policy/General
Federal Register Notice: FDA has announced a 3/9 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017–2018 influenza season. To view
FDA Policy/General
Federal Register Notice: FDA has announced a 3/17 joint Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee meeting. Panel members will discuss and make recommendations on potential risks related to misuse of peroxide-based contact lens products. Specific issues to be discussed
FDA Policy/General
Federal Register Notice: FDA has announced a 3/13 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. Panel members will be asked to discuss safety issues related to Endo Pharmaceuticals’ Opana ER (oxymorphone hydrochloride) extended-release tablets, indicated