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As part of the HHS Operation TrialBlazer, FDA has revised a draft guidance on demonstrating substantial evidence of effectiveness in drug and biologic trials.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
Devices
Resmed has recalled (Class 1) its Astral 100/150 ventilator system due to the potential for a supercapacitor electrolyte leakage on the printed circuit board assembly that may damage the charger chip, causing a fail-safe state and interruption of ventilation therapy. An FDA notice says the agency determined the
FDA Policy/General
Centers for Medicare & Medicaid Services head Mehmet Oz is increasingly viewed inside the Trump administration as the leading candidate to eventually succeed Robert F. Kennedy Jr. as HHS secretary, according to a Bloomberg report that cites administration officials, lobbyists and people familiar with internal deliberations. The report portrays Oz
Drugs
FDA has issued Dr. Reddy’s a three-observation Form FDA-483 following a pre-approval inspection and Good Manufacturing Practices inspection at the company’s FTO-SEZ Process Unit-02 in Srikakulam, Andhra Pradesh, India. The inspection was conducted between 7/ 20-29, according to the company. Dr. Reddy&
Devices
FDA has granted de novo authorization for Caristo Diagnostics’ CaRi-Heart, described by the company as the first and only technology authorized in the U.S. to quantify coronary inflammation from routine coronary CT angiography. A company statement says it will begin the CaRi-Heart commercial launch this quarter and
Biologics
An FDA advisory committee voted 9 to 3 against recommending approval for Capricor Therapeutics' investigational cell therapy deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD), dealing a significant setback to the company's approval bid ahead of an 8/22 user fee review decision target date.
Drugs
FDA has accepted for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatment for pyruvate dehydrogenase complex deficiency (PDCD), a rare and life-threatening mitochondrial disorder with no currently approved therapies. The agency has set a user fee review action target date of 12/
Drugs
FDA has released the 17-page form FDA-483 issued following a 5/12-5/20 inspection at the Strides Pharma Science drug manufacturing facility in Bangalore, Karnataka, India. The five inspection observations were: * failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications, standards, sampling
Drugs
FDA has just submitted the mandated FY 2024 report to Congress on the premarket approval of pediatric uses of medical devices. It is the 13th such report FDA has sent Congress as required by the Federal Food, Drug, and Cosmetic Act. During FY 2024, the report says, the agency approved
Drugs
FDA has released the form FDA-483 issued following a 4/13-4/17 inspection at the Novel Laboratories (Lupin) drug manufacturing facility in Somerset, NJ. The three specific inspection observations were: * failure to extend investigations of an unexplained discrepancy and a failure of a batch or any of its
FDA Policy/General
FDA is codifying some of the changes made during the early months of the second Trump administration and consolidating administrative staff activities across the agency’s nine Centers. An internal agency memo reviewed by NOTUS says FDA also will stop having specialized field inspectors as of 10/1. The reorganization
Drugs
A review of FDA complete response letters issued between 2018 and 2025 using the keyword “validation” indicates that in about 2% of the letters, the agency raised concerns about audit trails, system validation, spreadsheet controls, data lineage, and incomplete source data traceability. Writing in a BioProcess International column, clinical research
Drugs
FDA reviewers have raised substantial concerns about the clinical evidence supporting Replimune Group's BLA resubmission for accelerated approval of its investigational oncolytic immunotherapy, vusolimogene oderparepvec (RP1), in combination with nivolumab for patients with advanced melanoma whose disease progressed after prior PD-1 inhibitor treatment. In briefing documents released
Devices
A 2/4-3/6 FDA inspection at the Linemaster Switch Corp. facility in Woodstock, CT, found Quality System Regulation violations in the firm’s manufacturing of foot pedal accessories for medical devices. A just-released 5/3 Warning Letter says the specific violations were: * failure to perform rework following
Drugs
FDA says its review of a Web site maintained by VasoCorp, Inc., in Hiram, GA, determined that the company takes orders for two Nerve Support Formula products that are legally considered to be unapproved new drugs. A 7/9 Warning Letter says the drugs are not generally recognized as safe