News & Insights Search

Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) draft guidance on new approach methodologies (NAM), which aims to replace animal testing with innovative models, such as in silico modeling, to assess drug safety.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned of additional leadership turnover at the agency, including new acting chiefs for the agency’s drug and biologics centers, and the agency announced that it has concluded negotiations with industry to reauthorize its prescription drug user fee program.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

A Health Technology Assessment Regulation (HTAR) governance body has published guiding principles on data transparency.

Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.

The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.

An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.

The US Food and Drug Administration (FDA) has issued warning letters to two researchers for failing to meet good clinical practice (GCP) requirements and for not complying with their own trial protocols. The agency also cited several drug manufacturers for failing to adhere to current good manufacturing practices (CGMP).

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Industry groups and legal experts want the US Food and Drug Administration (FDA) to make significant revisions to a proposed guidance on how pharmaceutical manufacturers should address Form 483 observations after a current good manufacturing practice (CGMP) inspection.