Drugs
Osmotica Pharmaceutical is asking FDA to require that any ANDA seeking approval of venlafaxine HCl extended-release tablets 225 mg and referencing the company’s NDA-approved product demonstrate in vivo bioequivalence using the 225 mg strength. A 12/9 citizen petition says the agency generally recommends that in vivo
Drugs
FDA has extended until 4/10/2017 the comment period on its initiative to review “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” FDA says the comments will inform policy development in this area — something the agency has been uncomfortable with for a long time in the
Drugs
CDER is issuing more complete response letters this year, and it is significantly reducing the number of new molecular entity (NME) approvals, retiring Office of New Drugs director John Jenkins says in his annual review of the Center’s approval performance. Factoring in fewer NME submissions and five applications that
Drugs
FDA and HHS’ Office for Human Research Protections have released a guidance on “Use of Electronic Informed Consent (eIC) — Questions and Answers” that provides recommendations on procedures that may be followed when using an electronic informed consent. The document addresses topics such as how to present information in the eIC
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled “Public Notification of Emerging Postmarket Medical Device Signals” that describes CDRH’s policy for notifying the public about medical device emerging signals. It describes the factors the Center intends to consider in deciding whether to notify the public about an
FDA Policy/General
Federal Register Notice: FDA is making available a list of information collections that have been approved by the Office of Management and Budget. Approvals include: Agreement for Shipments of Devices for Sterilization; Export of Medical Devices—Foreign Letters of Approval; Mammography Facilities, Standards, and Lay Summaries for Patients; Substances Generally
FDA Policy/General
Federal Register Notice: FDA has announced a 4/6/2017 public meeting on “Patient-Focused Drug Development for Sarcopenia.” The meeting, which is being held at FDA’s White Oak, MD campus, is intended to allow the agency to obtain patient perspectives on the impact of sarcopenia on daily life
Drugs
FDA has approved an Anacor Pharmaceuticals NDA for Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. Approval was based on data from two placebo-controlled trials with a total of 1,522 participants ranging in age from two years
Drugs
FDA has selected Department of Justice Office of International Affairs attorney Donald D. Ashley as CDER’s next Office of Compliance director, effective 1/9/2017. Ashley replaces Cynthia Schnedar, who recused herself a year ago from working on substantive compliance actions because her husband, Mark Polston, had been named
Devices
FDA has finalized a guidance on “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) that describes CDRH’s policy for notifying the public about medical device “emerging signals.” According to the guidance, an emerging signal is new information about a marketed medical device: 1) that supports a new
Devices
CDRH says it does not require device makers to file Medical Device Reporting (MDR) submissions if their device is being used outside the U.S. for a different intended use and the malfunction or death or serious injury are related to that different use — and not the same use that
FDA Policy/General
Federal Register Notice: FDA is seeking comments on a new information collection related to “Donor Risk Assessment Questionnaire for FDA/National Heart, Lung, and Blood Institute (NHLBI)-sponsored Transfusion-Transmissible Infections Monitoring System (TTIMS) — Risk Factor Elicitation.” FDA intends to interview blood donors to collect risk factor information associated with
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for patent extension purposes of GlaxoSmithKline’s Nucala (mepolizumab) for use with other asthma medicines as maintenance treatment in patients 12 years and older is 6,862 days. Of this, 6,496 days occurred during the testing phase, while 366
FDA Policy/General
Federal Register Final Rule Correction: FDA is correcting a final rule entitled “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” that appeared in the 8/31 Federal Register. That final rule amended current
Drugs
FDA has approved a Vericel PMA for Maci (autologous cultured chondrocytes on porcine collagen membrane) for repairing symptomatic, full-thickness knee cartilage defects in adult patients. An agency release says Maci is the first approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Pocono Coated Products Cherryville, NC (10/27): FDA inspected the firm 10/2015 and documented significant GMP violations related to finished pharmaceuticals. For example, FDA cited the firm for
Drugs
President Obama 12/13 signed into law the 21st Century Cures Act, which will provide a $500 million funding boost for FDA over the next 10 years. The new law also builds on the agency’s “ongoing efforts to advance medical product innovation and ensure that patients get access to
Drugs
FDA says it has speeded up its release of drug safety information on its Web site that houses labeling changes made post approval. “Our improved Drug Safety Labeling Changes Program enables FDA to post the latest safety information about a medicine almost at the same time we approve a change,
Drugs
The Association of American Medical Colleges (AAMC) says that an FDA draft guidance on procedures for evaluating appearance issues and granting authorization for participation in FDA advisory committees would benefit from additional clarification. The association also says it is pleased that the agency drafted the document, which seeks to explain
Devices
Attorneys Nathan Brown, Marlee Gallant, and Eli Tomar (Akin Gump) say that new authorities in the 21st Century Cures Act give FDA greater flexibility in regulating medical devices, but their ultimate impact will depend on how they are implemented by the agency under a new administration. Writing in an online
Drugs
FDA says that as a result of an updated review, it has determined that using the Type 2 diabetes medicine pioglitazone (Takeda’s Actos, Actoplus Met, Actoplus Met XR, and generic combination drugs Duetact and Oseni) may be linked to an increased risk of bladder cancer. An agency drug safety
FDA Policy/General
Federal Register Notice: FDA has determined that sodium chloride 23.4% in a plastic container (sodium chloride), injectable, 234 milligrams/milliliter was not withdrawn from sale for safety or effectiveness reasons. This determination will allow the agency to approve generic sodium chloride, injectable, 234 mg/mL, if all other legal