Drugs
A 12/16-12/19/2025 FDA inspection at the Laboratorios Jaloma drug manufacturing facility in Oblatos, Guadalajara, Jalisco, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations. A 5/22 Warning Letter says the specific violations were: * failure to ensure that laboratory records included complete data derived
Drugs
FDA has published a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities: Questions and Answers, with answers to common questions about firms’ communication of health care economic information (HCEI) about their prescription drugs and medical devices to payors, formulary committees, or other similar entities
Drugs
FDA has released an International Council for Harmonization (ICH) guidance that establishes a global framework for using computational modeling and simulation in drug development, a move regulators hope will increase confidence in model-based evidence and expand its role in regulatory decision-making. The new guidance, M15 General Principles for
Drugs
FDA has released a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufacturing knowledge to streamline product development and regulatory review. The draft was issued as part of the current user fee agreement to provide recommendations on leveraging prior knowledge in cell and
Biologics
Former FDAer Peter Pitts, now president of the Center for Medicine in the Public Interest, writes that ALS (amyotrophic lateral sclerosis) “has become an important stress test for whether American regulatory institutions can adapt to 21st century biomedical science.” Writing in an open-source article in the Journal of the
Drugs
Animal Defenders International (ADI) is petitioning FDA to revise its regulations to remove prescriptive references to the rabbit pyrogen test (RPT) for testing drugs for pyrogenic substances and to permit the use of validated non-animal methods instead. The petition says that continuing to refer to the rabbit pyrogen test
Drugs
FDA has appointed Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency veteran to one of the top leadership positions within the agency's inspection and enforcement organization. She replaces Douglas Stearn who retired late last year. Romano, who most recently served
Drugs
Fulcrum Therapeutics says it is discontinuing development of its lead sickle cell disease candidate, pociredir, after receiving feedback from FDA that effectively closed the regulatory path for the drug. The biotechnology company announced June 1 that it had received In meeting minutes from a recent meeting with FDA, the agency
Drugs
Technical negotiations over the next iteration of the Prescription Drug User Fee Act have concluded, setting the stage for broader political and congressional debate over the future direction FDA’s drug review program, according to an analysis published 5/29 by the American Action Forum. In a commentary titled “PDUFA
Drugs
FDA has issued a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conjugated therapies, a move the agency said could reduce animal use and speed cancer drug development without compromising patient safety. The document, titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and
Drugs
The International Council for Harmonization has updated its long-running question-and-answer guidance tied to the ICH Q8, Q9 and Q10 pharmaceutical quality guidelines, adding new detail on real-time release testing, pharmaceutical quality systems and the role of knowledge management in modern drug manufacturing. The revised Q&
Drugs
FDA has cited BPI Labs for potential cross-contamination risks at its outsourcing facility in Largo, FL, according to an inspection report issued following an April inspection. Agency investigators inspected the facility from 4/6-17 and documented concerns involving cleaning verification procedures used on manufacturing equipment. According to the
Drugs
FDA has published two final guidances related to establishing bioequivalence. The first guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, has recommendations for applicants planning to submit bioequivalence (BE) information in ANDAs and amendments and supplements to ANDAs. The guidance describes how to meet the BE
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-naïve, high-risk non-muscle invasive bladder cancer, expanding the use of the company’s immunotherapy. The approval covers patients with high-risk non-muscle invasive bladder cancer, or NMIBC, following
Drugs
Former FDA associate commissioner Peter Pitts, who is now president of the Center for Medicine in the Public Interest, has been named to the BrainStorm Cell Therapeutics board of directors. A company announcement says that once it obtains funding, BrainStorm will start its Phase 3b ENDURANCE trial evaluating NurOwn for
Drugs
FDA says a 5/6-6/20/2024 Bioresearch Monitoring Program inspection of a clinical investigation conducted by Dr. Adnan Dahdul in Springfield, MA, found “objectionable conditions” in that Dahdul violated regulations governing the proper conduct of clinical studies involving investigational products. A just-released 3/12 Warning Letter says
Drugs
FDA is extending by 30 days the comment period on a request for information entitled “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program." Earlier this year, the agency announced it was seeking comments on how AI-enabled technologies can improve efficiency, speed, and quality of decision-making
Drugs
FDA has cited Dabur India Limited for significant manufacturing and data integrity violations at an over-the-counter drug manufacturing facility in India, according to a just-posted inspection report that detailed falsified records, questionable microbiology testing practices and sanitation problems. FDA issued a Form-483 following a 1/12-
Drugs
An 11/3-11/ 7/2025 FDA inspection at the GC America drug manufacturing facility in Alsip, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/14 Warning Letter says the specific violations were: * failure to test samples of each component for identity
Drugs
FDA has extended its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional data tied to a closely watched Phase 3 study that has drawn scrutiny from outside advisers. The company is seeking approval for camizestrant in combination with CDK4/6 inhibitors for first-
Drugs
Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushing’s syndrome, following additional analyses requested by FDA after issuing a complete response letter late last year. The company says FDA requested further analyses of data already included in the application. Corcept CEO Joseph
Drugs
FDA has approved an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy), a CD123-directed antibody and alkylating agent conjugate for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The agency says the approval was based in data from the CADENZA (NCT03386513) study, a multicenter, open-label, single-arm clinical trial