Drugs
FDA says its review of records and products submitted by Guangdong Bangze Medicine Co., Ltd., in Guangdong Sheng, China, in response to an agency 1/20 request, determined there were significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s production of over-the-
Drugs
A 6/2-6/6 FDA inspection at the Pritam International Private Limited drug manufacturing facility in Uttarakhand, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/27 Warning Letter says the agency also determined that the firm contract manufactures an over-the-
Drugs
FDA has placed a partial clinical hold on Bright Minds Biosciences' planned Phase 2 trial of BMB-101 in patients with developmental and epileptic encephalopathies (DEEs), citing toxicity findings in mice and insufficient pharmacokinetic and juvenile toxicity data to support pediatric enrollment. The proposed U.S. trial is a
Drugs
FDA has extended by three months its review of an Agios Pharmaceuticals supplemental NDA for mitapivat, an oral pyruvate kinase (PK) activator, for treating sickle cell disease. The user fee review action target date is now 2/1/2027. The company says FDA recently requested additional information to evaluate whether
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) issued 30 enforcement letters during fiscal year 2026, including 28 untitled letters and two warning letters, according to office director Twyla Mosey, who told a Food and Drug Law Institute conference that many promotional violations might have been avoided if drugmakers had
Drugs
FDA has posted an International Council for Harmonization revised final guidance to clarify how drug developers should evaluate the potential for investigational drugs to prolong the QT/QTc interval and cause potentially serious cardiac arrhythmias, including circumstances in which traditional clinical cardiac safety studies may not be feasible. The guidance,
Drugs
Former FDA principal deputy commissioner, acting commissioner, and CDER director Janet Woodcock says reforms are needed to make individualized gene therapies a viable development opportunity for rare diseases. Writing in a BioCentury online commentary, Woodcock says FDA already has the statutory authority to address several of the barriers preventing the
Drugs
Vanda Pharmaceuticals and FDA are asking a federal judge to resolve a dispute over the agency's partial clinical hold on a yearlong trial of tradipitant for gastroparesis, with the company arguing that FDA's insistence on additional animal toxicity testing violates the FDA Modernization Act 2.0
Drugs
FDA has accepted for review a resubmitted NDA for Izipry (naloxone nasal powder), a high-dose naloxone rescue medication for opioid overdose. The agency has set a user fee review action target date of 3/29/2027. Izipry is being developed using Orexo’s proprietary AmorphOX powder-based drug delivery
Drugs
FDA has published an updated Concept of Operations outlining how CDER and the Office of Inspections and Investigations (OII) (formerly the Office of Regulatory Affairs) “collaborate in a coordinated, programmatically aligned environment regarding marketing application assessment, inspections, and related activities.” The document covers preapproval, postapproval, surveillance, and for-cause inspection
Drugs
A Duke Margolis Institute for Health Policy white paper, “From Research to Care: Modernizing U.S. Clinical Studies for Cures Into Care,” lists several priority actions that it says private organizations and collaborations need to take to reform the U.S. fragmented clinical research system. The report reviews the current
Drugs
FDA’s recent final guidance Regulatory Considerations for Prescription Drug Use-Related Software provides sponsors with a “more concrete framework for navigating the boundary between FDA-required and promotional labeling, while placing a premium on early regulatory planning,” according to a new Akin legal analysis. The guidance outlines how prescription
Drugs
A 9/25 joint FDA/European Medicines Agency (EMA) workshop on “Regulatory Perspectives on Herbal Medicinal/Botanical Drug Development” set the stage for future joint activities in the herbal/botanical space, despite regulatory differences in the ways in which the two jurisdictions approach the products. An interview in an FDA
Drugs
Eli Lilly is reporting “positive topline results” from TRANSCEND-T2D-2, a head-to-head Phase 3 trial comparing retatrutide with Novo Nordisk’s injectable Ozempic 2 mg in adults with Type 2 diabetes. “At 80 weeks, retatrutide met the primary and all key secondary endpoints, delivering greater A1C reduction
Drugs
FDA has issued a Warning Letter to Amgen over a promotional video for its colorectal cancer drug Vectibix (panitumumab) because it omitted all safety information and failed to disclose important limitations on the drug’s approved uses. In the just-posted 8/12 Warning Letter, CDER’s Office of Prescription
Drugs
A federal judge has denied Novo Nordisk’s request for a preliminary injunction blocking Eli Lilly from running allegedly misleading advertisements comparing its GLP-1 drugs Zepbound and Mounjaro with Novo’s Wegovy and Ozempic, finding that Novo failed to demonstrate irreparable harm. In a 10/26 opinion, U.S.
Drugs
A 5/26-5/29 FDA inspection at the Northland Nuclear Medicine drug manufacturing facility in Bismarck, ND, found repeat current good manufacturing practice (CGMP) violations in the firm’s production of positron emission tomography (PET) drugs. A 10/22 Warning Letter says the firm’s PET drugs are adulterated
Drugs
An FDA review of records requested from Sanrace Biotechnology Co. in Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/22 Warning Letter says the specific violations were: * failure to conduct at least one test to verify the identity of each
Drugs
Failures to establish or follow written quality procedures and inadequate investigations of manufacturing problems were the most frequently cited deficiencies in FDA drug-quality inspections conducted during 2026, according to an FDA Webview analysis of agency inspection data. FDA cited deficiencies involving written quality-unit procedures in 74 inspections, representing
Drugs
Brand-name and generic drug manufacturers are urging FDA to revise its proposed guidance (see earlier story) on determining whether sponsors should submit an ANDAor a 505(b)(2) application, with the two industry groups emphasizing different concerns about the agency's interpretation of the approval pathways. In separate
Drugs
BreakBio, a biotechnology company developing personalized cancer immunotherapies, has appointed former FDA Commissioner Stephen M. Hahn, who led the agency from 12/2019 to 1/2021 during the first Trump Administration, as an advisor. The company says Hahn will advise BreakBio on clinical development, regulatory strategy, oncology, platform development and
Drugs
A citizen petition filed by Foley & Lardner urges FDA to require mandatory monthly immunoglobulin monitoring and explicit treatment-interruption instructions in the prescribing information for Vertex Pharmaceuticals' investigational IgA nephropathy treatment povetacicept, ahead of an 11/30 user fee review action target date. The 10/21 petition contends