FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that a direct-to-consumer TV ad for Sanofi-Aventis’ Toujeo (insulin glargine injection) U-300, for subcutaneous use, makes false or misleading representations about the risks associated with the drug. A 12/12 Notice of Violation says the violation “is
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that a TV spot for Celgene’s Otezla (apremilast) makes false or misleading representations about the drug’s risks and is concerning from a public health perspective by creating a misleading impression about the drug’s safety. A 12/12 Notice
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
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
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
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
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids.” The document discusses the agency’s intention not to enforce certain conditions for sale for hearing aid devices. Specifically, it does not intend to enforce the medical
FDA Policy/General
DEVICES Class 2 for Computerized Concussion Assessment Aids Federal Register Final Order: FDA has classified Computerized Cognitive Assessment Aids for Concussion into Class II (special controls). The special controls that will apply to the device are identified in the order and will be part of the codified language for the
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The document is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the
FDA Policy/General
Federal Register Notice: FDA has established a docket to obtain comments on the final assessment of the “Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs).” Also, a 3/27/2017 public meeting has been annouced where
FDA Policy/General
Former FDA deputy commissioner Scott Gottlieb, who served under George W. Bush, has reportedly been added to the short list of candidates president-elect Donald Trump is considering for FDA commissioner under his administration. Gottlieb, who is also serving on the Trump transition team, is a resident fellow at the
FDA Policy/General
Federal Register Notice: FDA has made available data extracted from adverse event reports from 2004 to the present for food (including food additives, color additives, and dietary supplements) and cosmetics regulated by CFSAN. The data files are being made publicly available on the agency’s Web site to improve transparency
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Merck’s Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) for patent extension purposes is 2,662 days. Of this time, 2,296 days occurred during the testing phase, while 366 days occurred during the approval phase. To view
FDA Policy/General
One week after the House passed the 21st Century Cures Act, the Senate has voted 94 to 5 to pass the bill, and it now heads to president Obama’s desk for signing. After the vote, Senate Health, Education, Labor and Pensions committee chair Lamar Alexander (R-TN) called the
FDA Policy/General
CDER deputy director for regulatory programs Douglas Throckmorton says that FDA’s work to improve the safe use of opioids is “taking place within a larger policy framework aimed at addressing opioid abuse while supporting appropriate access to pain treatment. In an update on the agency’s opioid action plan,
FDA Policy/General
Federal Register Final Order: FDA has classified Computerized Cognitive Assessment Aids for Concussion into Class II (special controls). The special controls that will apply to the device are identified in the order and will be part of the codified language for the device’s classification. To view the order, click
FDA Policy/General
Federal Register Notice: FDA has extended the comment period related to its public meeting on “Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products.” Comments are sought on the approach to testing that FDA recommended in its draft guidance on “General Principles for Evaluating the Abuse Deterrence of
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” The document is intended to assist applicants in complying with FDA regulations. To view the notice, click here.