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The US Food and Drug Administration (FDA) sent a warning letter on 10 March to Novo Nordisk at its Plainsboro, NJ, site for a raft of postmarketing adverse drug experience (PADE) violations, including failing to report adverse events for patients taking the company's GLP-1 treatments indicated for diabetes and weight management.

Simone Pitts, a pharmaceutical investigator in the Office of Human and Animal Drug Inspectorate (OHADI) at the US Food and Drug Administration (FDA), stated that inadequate oversight of manufacturing operations by the quality control unit (QCU) was the top deviation identified in Form 483 inspection reports for pharmaceutical companies during FY 2024.

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection. This guidance applies to both domestic and international inspections.

The core mission of the US Food and Drug Administration's (FDA) inspections program, as well as how it prioritizes inspections, has remains unchanged despite recent leadership changes at the agency, said Ivy Sweeney, deputy director of the Office of Human and Animal Drug Inspectorate (OHADI).

The US Food and Drug Administration (FDA) issued warning letters to a medical device manufacturer and a homeopathic drug manufacturer for failing to meet current good manufacturing practices (CGMP) requirements. The agency also cited another device maker for marketing products without authorization and failing to comply with clinical trial requirements.

The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual facility fees for the first three years for companies that establish manufacturing operations for finished generic drugs or active pharmaceutical ingredients (APIs) in the US during user fee negotiations.

The US Food and Drug Administration (FDA) has issued warning letters to a contract drug maker for failing to meet current good manufacturing practices (CGMP) and a clinical investigator for failing to ensure site staff complied with the clinical investigation plan.

The pharmaceutical industry groups are suggesting that the US Food and Drug Administration (FDA) automatically schedule a post-inspection meeting whenever it issues a Form 483 to manufacturers following a preapproval inspection (PAI). Additionally, industry is requesting that FDA respond within 15 days after receiving companies' responses to the Form 483.

The US Food and Drug Administration (FDA) officially launched its PreCheck pilot program on Sunday and is now accepting applications from manufacturers who wish to participate. In announcing the program, the agency rejected the pharmaceutical industry's suggestions to allow existing facilities to participate in the program.

US Food and Drug Administration (FDA) Commissioner Marty Makary said he wants to see the same sense of urgency given to Operation Warp Speed applied to the agency's Commissioner's National Priority Voucher (CNPV) program.

The European Commission's Medical Device Working Group (MDCG) has issued guidance on Tuesday outlining the criteria for a device to qualify as a breakthrough (BtX) device under the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR).

WASHINGTON – The top compliance official at the US Food and Drug Administration's (FDA) biologics center said it is imperative for sponsors to schedule preapproval inspections (PAIs) at the midpoint of the review cycle, rather than waiting till later on in the process. Waiting till late in the review process could jeopardize an application, as sponsors will have less time to address any inspection issues.

Washington, DC – Experts said that the US Food and Drug Administration (FDA) should provide more clarity on how it intends to regulate the use of artificial intelligence and large language models when they are used in the development or manufacture of a product but are not part of the product itself.

WASHINGTON – The US Food and Drug Administration's (FDA) Jill Furman, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), reported that there has been a 50% increase in warning letters issued by CDER in FY 2025. She noted that a significant portion of this increase is due to letters sent to telehealth platforms that are making false claims about compounded drug products.

The US Food and Drug Administration (FDA) recently posted four warning letters to pharmaceutical manufacturers in the US, Canada, and China for violations of current good manufacturing practices (CGMPs) and for marketing unapproved drug products.

The US Food and Drug Administration (FDA) issued draft guidance for device makers that outlines its expectations for implementing the Quality Management System Regulation (QMSR). The guidance details the information that should be included to support Premarket Approval Applications (PMAs) and Humanitarian Device Exemption (HDE) applications, ensuring alignment with the QMSR.

The US Food and Drug Administration (FDA) recently published three warning letters it sent to medical device manufacturers in China and Switzerland over quality system and current good manufacturing practices (CGMP) violations.

The US Food and Drug Administration (FDA) on Tuesday reprimanded a US manufacturer and contract testing lab, BRS Analytical Services, for producing eye drops under unsanitary conditions, and an Australian company, Melcare, for making unapproved drug claims regarding their eye drops.

The World Health Organization (WHO) issued an alert on Monday identifying oral cough syrups manufactured in India that contain diethylene glycol (DEG), a substance typically used as an industrial solvent and in antifreeze. According to the BBC, at least 20 children in India have died after ingesting these cough syrups.

The European Medicines Agency (EMA) has begun accepting the Food and Drug Administration's (FDA) findings from inspections of facilities outside the US.