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The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and purchasing, and complaint handling and feedback.

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good manufacturing practice (CGMP) requirements, and one firm that has failed to submit an approved application for premarket approval (PMA).

The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for noncompliance with current good manufacturing practices (cGMPs). Additionally, FDA sent an untitled letter was to Incyte for making misleading claims about a product on its website.

The US Food and Drug Administration (FDA) recently sent warning letters to three companies concerning facilities in India and one in Germany for current good manufacturing practices (GMPs) and nonclinical study-related violations.

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The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.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 European Medicines Agency (EMA) has published a concept paper outlining topics that it wants to address in a reflection paper on non-clinical development of microbiome-based medicinal products (MMP). The agency said the paper should address issues such as the diversity of MMPs and the different areas of the body they target.

The International Medical Device Regulators Forum (IMDRF) has published two new documents to help regulators and sponsors harmonize adverse event terminology and support regulatory reliance across regulatory agencies. The international group stated that regulatory reliance may help streamline activities by leveraging trusted regulatory authorities and that harmonizing adverse event terminology can help regulators detect safety signals sooner.

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 UK's Medicines and Healthcare products Regulatory Agency (MHRA) is requesting feedback on a proposal to allow EU CE-marked medical devices sold in Great Britain to be recognized and sold indefinitely. This measure aims to ensure a continuous and uninterrupted supply of these devices. The announcement was made as part of a targeted consultation on Monday.

BETHESDA, MD – Companies should increase their efforts to address issues and test their electronic Common Technical Document (eCTD) Version 4.0 before it becomes mandatory, according to regulators with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).