Drugs
FDA regulatory experts broadly praised the agency's new "Operation Trialblazer" initiative as an important step toward accelerating drug development but cautioned that lingering leadership turnover and regulatory uncertainty continue to weigh on investment in biotechnology, particularly in the cell and gene therapy sector. During the latest
Drugs
FDA has cited Australian manufacturer Veganic SKN Limited for multiple current good manufacturing practice deficiencies following a 7/2025 inspection of its Rocklea, Queensland facility, according to a just-posted five-page Form FDA 483 issued at the close of the inspection. The inspection, conducted at the company's
Biologics
A new FDA draft guidance is outlining how sponsors should develop and evaluate container closure systems and device components used with biosimilar and interchangeable biosimilar products, providing a clearer framework for demonstrating that design differences from reference products do not compromise safety or effectiveness. The document focuses on therapeutic protein
Drugs
A new Harvard Law School legal commentary post argues that decades of policies designed to accelerate pharmaceutical innovation may have instead encouraged investment in drugs that offer limited clinical benefit while leaving important public health needs underserved. Legal scholars Daniel Aaron and Avery Emery contend that any debate over whether
Drugs
FDA has finalized a guidance outlining how generic drug developers should evaluate the adhesion performance of transdermal and topical delivery systems, providing updated recommendations intended to standardize studies supporting ANDAs for products such as patches and extended-release films. FDA says consistent adhesion is a critical quality attribute because the
Drugs
Novo Nordisk says its investigational anti-inflammatory drug ziltivekimab failed to reduce the risk of major adverse cardiovascular events in a late-stage study of patients with cardiovascular disease, chronic kidney disease and inflammation, marking a setback for the company's efforts to develop a new treatment targeting the
Drugs
FDA has issued a revised draft guidance updating its recommendations for how generic drug developers should evaluate the skin irritation and sensitization potential of transdermal and topical delivery systems submitted in ANDAs. The guidance provides recommendations for designing and conducting in vivo studies comparing proposed generic transdermal or topical delivery
Drugs
FDA has approved Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen- (PSMA) positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, broadening the radiopharmaceutical's use into an earlier stage of the
Biologics
Sen. Ron Johnson (R-WI), chairman of the Senate Permanent Subcommittee on Investigations, has requested that former CBER director Peter Marks, former CDER officials Narayan Nair, Steven Anderson, and Manette Niu, and former National Institute of Allergy and Infectious Diseases director Anthony Fauci appear for transcribed interviews about their roles
Biologics
FDA has accepted for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma. If approved, it would provide a new treatment for patients whose disease has progressed following platinum-based chemotherapy
Drugs
FDA has cited contract drug manufacturer Cerovene Inc. for repeat current good manufacturing practice (CGMP) deficiencies following a 3/16-23 inspection of its Valley Cottage, NY facility, according to a just-posted Form FDA 483. The agency documented three observations, including repeat findings involving equipment cleaning and computerized systems
Drugs
A Friends of Cancer Research survey of eight drug companies with global oncology drug development programs determined that the U.S. excels at initial clinical trial site activation, but lags in scaling up site activation. The report says the first U.S. sites were activated a median of 124 days
Drugs
FDA has cited Gasco Industrial Corp. for significant and repeat GMP deficiencies following a 2/17-27 inspection of the company's over-the-counter drug manufacturing facility in Gurabo, Puerto Rico. The Form FDA 483 indicates the inspection was conducted as a follow-up to deficiencies previously identified
Drugs
FDA has classified a correction involving certain Argon Medical convenience kits as a Class I recall after identifying risks associated with lidocaine ampules supplied as components in the kits. The action does not require removal of the kits from hospitals or other users, but instead instructs customers to remove and
Biologics
A 5/5 FDA guidance on chemistry, manufacturing, and controls flexibilities for developing human cellular and gene therapy (CGT) products is changing the landscape of regulatory approval for such products. A BioProcess International online column analyzing the guidance, which is being implemented immediately, says FDA has abandoned its long-standing
Drugs
A 7/13 FDA proposed rule would fundamentally change how certain drug manufacturers register their facilities and list their products with the agency. Attorneys Abha Kundi and Shoshanna Golden (Argent Fox Schiff) write in an online post that the proposal is consistent with recent agency initiatives intended to strengthen U.
Biologics
FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee has voted 10 to 3 to recommend approval of Replimune's experimental oncolytic immunotherapy RP1 (vusolimogene oderparepvec) in combination with Bristol Myers Squibb's Opdivo for patients with advanced melanoma, despite FDA reviewers' conclusions that the application lacked
Drugs
As part of the HHS Operation TrialBlazer, FDA has revised a draft guidance on demonstrating substantial evidence of effectiveness in drug and biologic trials. Attorneys William McConagha and Trevor Thompson (Latham Watkins) say that while the revised guidance does not change the underlying statutory or regulatory paradigm for demonstrating substantial
Drugs
FDA has released the form FDA-483 issued following a 3/23-3/27 inspection at the Allure Labs manufacturing facility in Hayward, CA. The three specific inspection observations were: * failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications,
Drugs
FDA has accepted for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery. The agency set a user fee review action target date of 11/28. The company says D-PLEX100 is designed to provide local prolonged
FDA Policy/General
FDA has published the following user fee rates for medical product programs for fiscal year (FY) 2027: Prescription Drug User Fee Rates for FY 2027: *** NDA/BLA requiring clinical data: $4,600,753 (FY 2026 $4,682,003) *** NDA/BLA not requiring clinical data: $2,300,376 (FY 2026 $2,
Drugs
FDA has released the form FDA-483 with nine observations from a 3/16-3/27 inspection at the Bentley Laboratories over-the-counter drug manufacturing facility in Edison, NJ. The specific observations were: * reports of analysis from component suppliers are accepted in lieu of testing each component for conformity