FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.” The agency requests feedback using a variety of methods to gain useful insights into customer or stakeholder perceptions, experiences, and expectations; provide an early warning
FDA Policy/General
Federal Register notice: FDA is correcting a 7/13/2022 notice that announced the regulatory review period determination for Genentech’s Enspryng (satralizumab-mwge), indicated for treating neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody positive. The original notice should have stated that the regulatory
FDA Policy/General
FDA and the Veterans Health Administration (VHA) are announcing a new memorandum of understanding (MOU) to help increase medical product manufacturing capacity and flexibility, and “improve resilience of domestic supply chains during emergencies, shortages, and pandemics. The MOU is intended to develop requirements for “trusted networks needed to enable the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of Abbott’s NDA for Cyclert (pemoline) tablets, indicated for treating attention-deficit/hyperactivity disorder. The company stopped marketing the product in 2005 in response to an agency safety alert about liver toxicity. The NDA was never officially withdrawn and Abbott is now
FDA Policy/General
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, bioequivalence study designs to support ANDA submissions. To view the notice, click here.
Drugs
New FDA research on direct-to-consumer (DTC) television ads found that study subjects have trouble differentiating progression-free survival and overall response rate from overall survival. The agency says research has suggested that disclosures can help consumers stop conflating overall survival with other endpoints. Such disclosures specifically state that
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations.” The document addresses selected clinical, scientific, and ethical issues involved in developing drugs, including biological products, for pediatric use when such
FDA Policy/General
Federal Register notice: FDA makes available a draft guidance entitled “Pediatric Drug Development: Regulatory Considerations — Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act.” The document describes the process for qualifying for pediatric exclusivity and the protections that pediatric exclusivity
FDA Policy/General
The House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies slashed $600 million (8.3%) from the Biden administration's 2024 proposed budget for FDA. The spending bill, which now moves to the full committee, provides $3.5 billion in direct budget authority, and
FDA Policy/General
Federal Register notice: FDA is making available its annual compilation of notices of updates to the agency’s antimicrobial test interpretive criteria Web page with updates made in 2021 and 2022. The Susceptibility Test Interpretive Criteria Web page was established in 2017 to provide updates on the susceptibility test interpretive
FDA Policy/General
Federal Register notice: CDRH is announcing a 9/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on advancing health equity in medical devices. The Center says technology, including digital health technology, may help bridge gaps in health equity by extending access and bringing healthcare to patients
FDA Policy/General
FDA commissioner Robert Califf says he’s cautiously optimistic that the U.S. could be on the verge of seeing major impacts from new drugs for treating Alzheimer’s and obesity. Presumably addressing Eli Lilly’s recent and promising news on its Alzheimer’s drug donanemab (see story) and its
FDA Policy/General
In a “reverse-FOIA” case, an attorney who works for a company that is regulated by FDA and was inspected by the agency in 2022 filed suit on 5/16 in the DC federal court to block FDA from releasing the attorney’s identity in connection with the form FDA-
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Intact Vascular’s Tack Endovascular System, indicated for use in the superficial femoral and proximal popliteal arteries to repair post-percutaneous transluminal balloon angioplasty dissections. The review period was 1,338 days, of which
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Cipla USA’s Zemdri (plazomicin), indicated for treating patients 18 years of age or older with complicated urinary tract infections. The review period was 3,447 days, of which 3,203 days occurred during
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Sanofi’s Cablivi (caplacizumab-yhdp), indicated for treating adult patients with acquired thrombotic thrombocytopenic purpura in combination with plasma exchange and immunosuppressive therapy. The review period for Cablivi is 2,998 days, of which 2,
FDA Policy/General
FDA has approved Allergan Aesthetics’ Skinvive by Juvéderm and its use to improve skin smoothness of the cheeks in adults over the age of 21. The company says it is the first hyaluronic acid intradermal microdroplet injection for skin smoothness available in the U.S. with results lasting through six
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals’ Onpattro (patisiran), indicated for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. The review period for Onpattro is 1,901 days, of which 1,658 days occurred during the testing phase and
FDA Policy/General
Federal Register notice: FDA is announcing its final decision rendered last month to withdraw approval of Covis Pharma Group’s Makena (hydroxyprogesterone caproate injection) and eight ANDAs that reference the product. The drug had previouslyreceived accelerated approval to reduce the risk of preterm birth in women pregnant with one baby
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.” The document provides revised donor deferral recommendations for individuals with increased risk for transmitting human
FDA Policy/General
Federal Register notice: FDA has determined that 18 drug products listed in the notice were not withdrawn from sale due to safety or effectiveness concerns. The determination allows the agency to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. To
FDA Policy/General
FDA has approved Astellas Pharma’s Veozah (fezolinetant), an oral drug for treating moderate-to-severe vasomotor symptoms (hot flashes) caused by menopause. The drug is the first neurokinin 3 (NK3) receptor antagonist approved for the indication, according to an agency release. It works by binding to and blocking the