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&
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
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
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
Drugs
FDA has issued a final guidance encouraging sponsors of oncology clinical trials to broaden eligibility criteria by including more patients with reduced performance status, arguing that less restrictive enrollment could make study populations more representative of patients treated in routine clinical practice. The guidance, “Cancer Clinical Trial Eligibility Criteria: Performance
Drugs
An FDA briefing document released ahead of a 7/29 Cellular, Tissue, and Gene Therapies Advisory Committee meeting reviewing Capricor Therapeutics’ resubmitted deramiocel for treating cardiomyopathy in male patients with Duchenne muscular dystrophy (DMD) says the company’s Phase 3 HOPE-3 study failed to meet its pre-specified primary
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FDA has issued a final guidance encouraging cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomitant medications, arguing that unnecessarily restrictive requirements can slow patient enrollment and limit the applicability of trial results to real-world populations. The guidance, “Cancer Clinical Trial Eligibility
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A final FDA guidance is urging sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to patient participation while maintaining appropriate safety protections. The agency said overly restrictive laboratory requirements can limit enrollment, reduce trial diversity, and make study results less representative of
Drugs
FDA is announcing an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investigational New Drug (IND) Pilot Program, an initiative designed to shorten the time between drug discovery and the start of first-in-human clinical trials. The one-hour webinar (9:00 a.
Drugs
Amgen has submitted to FDA new scientific data and analyses in its bid to prevent the withdrawal of Tavneos (avacopan), arguing that the treatment continues to demonstrate a favorable benefit-risk profile for patients with severe active ANCA-associated vasculitis (AAV), a rare and potentially life-threatening autoimmune disease. The
Drugs
FDA has issued a Complete Response Letter (CRL) to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate solution drug-device combination product, seeking an indication for use in adults as adjunctive therapy for treating peptic ulcers by reducing the amount of acid produced.The
Drugs
FDA has issued a Form 483 to Bausch + Lomb following a 3/12-20 inspection of the company's sterile drug manufacturing facility in Tampa, FL, identifying multiple observations involving complaint investigations, aseptic manufacturing practices, environmental monitoring, and quality system controls. One observation focused on complaint handling. FDA investigators
Drugs
FDA has published a strategy document on facilitating Chemistry, Manufacturing, and Controls (CMC) readiness for products with accelerated clinical development. The document says its publication completes the four CMC items the agency agreed to do under PDUFA 7. The strategy document says FDA: * published a CDER Manual of Policies and
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Bringing the keynote address at the Society of Cardiovascular Computed Tomography’s annual meeting, former FDA commissioner Rob Califf warned that efforts need to be made if the nation’s overall population health outcomes are to improve. He said the U.S. faces a troubling paradox in which revolutionary advances