FDA Policy/General
The Public Citizen Health Research Group says there are three things FDA can do to optimize its use of and processes for advisory committees. In a comment letter, Public Citizen recommends that the agency: * maintain or perhaps expand voting questions as a central feature of advisory committee meetings; * release sponsor
Drugs
FDA says it received 14 submissions to CDER in FY 2023 that contained real-world evidence (RWE). An online statement, provided to fulfill a PDUFA 7 commitment, says 10 of the submissions were for IND protocols and four were for NDAs or BLAs. For the protocols, the post says, nine
Drugs
A 10/31-11/3/2023 FDA inspection at the Sani-Care Salon Products drug manufacturing facility in Cartersville, GA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/24 Warning Letter says the specific violations were: * failure of the firm’s
Biologics
A 1/22-2/1 FDA inspection at the Indiana Lions Eye Bank, doing business as VisionFirst Indiana Lions Eye Bank in Carmel, IN, found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 6/10 Warning Letter says the “items of concern”
Drugs
The CDER New Drug Regulatory Program (NDRP) has had some successes since its inception in 2017 and is now a permanent initiative, according to Office of New Drugs Special Program Staff associate director Yoni Tyberg. Writing in an online CDER Conversation, Tyberg says the modernization aimed to increase the efficiency
Devices
Advanced Medical Technology Association (AdvaMed) says there are inconsistencies and ongoing concerns with FDA’s guidance entitled “Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff.” In comments submitted about the final guidance, AdvaMed contends that when an earlier draft
Drugs
Regeneron says FDA should consider developing a late-stage precision medicine guidance focused on common diseases to enable the application of “-omics” in late-stage clinical development (Phase 3). Commenting on an FDA notice soliciting comments on “Promoting Effective Drug Development: Identifying Opportunities and Priorities for FDA’s Office of
Drugs
Glenmark Pharmaceuticals is recalling (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg) 10 mEq K, due to dissolution failures. “The failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heartbeat that can
Biologics
A House Judiciary subcommittee interim staff report issued 6/25 claims to detail “how the Biden administration pressured FDA to go beyond its regulatory authority to change its procedures, cut corners, and lower agency standards to approve the Pfizer Covid-19 vaccine and authorize boosters. This approval enabled the Biden
Drugs
FDA has issued AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuations in adults with advanced Parkinson’s disease. In the letter, the agency cited observations that were identified during an inspection of a third-party manufacturer listed in the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Laboratory Developed Tests (LDTs): Small Entity Compliance Guide.” The document is intended to help small entities comply with applicable medical device regulations, consistent with the LDT final rule, including a phase-out of FDA’s general enforcement discretion approach
Drugs
FDA has accepted for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with sertraline for treating adults with post-traumatic stress disorder (PTSD). The agency has set a 2/8/2025 user fee review action target date. The submission is based on data from
Drugs
FDA has approved Halozyme Therapeutics’ Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Previously, the product was approved for treating adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive. CIDP is a rare immune-mediated, inflammatory, peripheral nerve disorder
FDA Policy/General
Federal Register notice: FDA is announcing a 7/22 public workshop entitled “Best Practices for Meeting Management” to discuss issues related to submission of meeting requests, efficient time management, finalizing meeting agendas, development and submission of meeting background packages, and lessons learned from the Covid-19 pandemic including the use
FDA Policy/General
Federal Register notice: FDA is announcing a publication containing modifications it is making to the list of standards FDA recognizes for use in premarket reviews. This publication, “Modifications to the List of Recognized Standards, Recognition List Number: 062,” is intended to assist manufacturers who elect to declare conformity with consensus
FDA Policy/General
Federal Register notice: FDA has determined that Janssen Pharmaceuticals’ Invega (paliperidone) extended-release tablet, 1.5 mg, was not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to continue to approve ANDAs that referenced the product as long as they meet relevant legal and
Drugs
FDA has converted Janssen’s Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory trial verified clinical benefit. Sirturo is indicated for treating pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis that is resistant to at least rifampin and isoniazid. The agency says the National TB Surveillance
Drugs
FDA has posted a guidance entitled “Laboratory Developed Tests: Small Entity Compliance Guide.” The document discusses the agency’s phase-out approach for laboratory-developed tests (LDTs) so that in-vitro diagnostics manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs (i.e., FDA’
Devices
FDA has approved an Endotronix PMA for its Cordella Pulmonary Artery (PA) Sensor System for treating New York Heart Failure Class III heart failure patients. The device is the “only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide
Drugs
The House Energy and Commerce Committee is seeking additional inspection records from FDA after a recent committee analysis of the foreign drug inspection program found troubling issues. In looking at inspections in India and China from 1/2014 to 4/2024, the committee says its analysis revealed “tremendous variation in
Drugs
FDA has denied a 4/2023 petition (see earlier story) that called on the agency to withdraw approval for Harmony Biosciences’ Wakix (pitolisant) and take other actions against the drug. Wakix has been indicated to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The petition said Scorpion founder
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “‘Considerations in Demonstrating Interchangeability With a Reference Product: Update.” The document describes considerations about a switching study or studies intended to support a demonstration that a proposed therapeutic protein product is interchangeable with a reference product. FDA says regulatory