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
Drugs
The Pharmaceutical Research and Manufacturers of America (PhRMA) is urging FDA to revise and clarify its draft guidance on using quantitative systems pharmacology (QSP) models to select starting doses in first-in-human clinical trials, arguing that the document should better align with international standards while providing greater flexibility for
Drugs
FDA issued a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing facility in Daman, India, citing significant quality system deficiencies, including failures to adequately investigate out-of-specification (OOS) and out-of-trend (OOT) test results.
Drugs
FDA has released 17 revised draft product-specific guidances (PSGs) for peptide products, which it touts as a “significant advancement in the agency’s scientific and regulatory approach to generic peptide drug assessment.” The revised draft PSGs address the following peptide products: * Calcitonin salmon (Calcimar, NDA 017769) * Calcitonin salmon (Miacalcin,
Drugs
Novo Nordisk has filed a motion for a preliminary injunction in the New Jersey District Court, seeking to stop Eli Lilly's “misleading” GLP-1 advertising campaigns while an earlier Novo Nordisk lawsuit proceeds. The move follows Novo Nordisk's lawsuit last week (see story) alleging that ads
Biologics
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with the agency well before a BLA filing to help avoid delays and common regulatory pitfalls. According to a just posted transcript, officials from CBER's Office of