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The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.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

Drugmakers should establish 'sustainable compliance practices” based on a strong quality culture, rather than simply doing the minimum required to pass inspections to avoid receiving a Form 483 or warning letter, said Donald Ashley, principal for regulatory compliance at Eliquent Life Sciences, during a webinar sponsored by the Food and Drug Law Institute (FDLI) on Wednesday.

More than half of medical device companies in the EU have reduced their product portfolios to cope with the complexities of the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR), while 17% have stopped producing devices entirely due to high certification costs and administrative burden.

The US Food and Drug Administration (FDA) on Thursday issued warning letters to 12 manufacturers and retailers for illegally marketing breast binders to children for gender-affirming surgery. The warning letters focus on companies' failure to register their devices, which are now considered Class I medical devices.

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.

The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with the updated Good Manufacturing Practices (GMPs) for medical gases, which will take effect on 18 December 2025. These GMPs are tailored to the manufacturing, processing, and storage of medical gases.

The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing practices (cGMPs), which included issues related to data integrity.

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.

BETHESDA, MD ­­­— Lilun Murphy, the director of the US Food and Drug Administration's Office of Generic Drugs (OGD), issued a warning to manufacturers regarding a recently identified leachable nitrosamine in certain drug products that are packaged in infusion bags.