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New clinical trial regulations came into force in the UK this week, marking the biggest change in the law on running human studies in the country in more than 20 years.

WHITE OAK, MD – The US Food and Drug Administration (FDA) has announced plans for a future pilot program intended to facilitate the real-time review of clinical trials by regulators, as well as the launch of two proof-of-concept studies that will gather and report endpoints and other signals to regulators in real time.

Fewer than half of the studies funded by the US National Institutes of Health (NIH) examined sex differences, despite a 2016 policy requiring grantees to report on them, according to a study published in Nature Communications Medicine.

Most drug and biological manufacturers met their postmarketing requirements (PMR) and postmarketing commitments (PMC) during fiscal year (FY) 2024, according to a report from the US Food and Drug Administration (FDA).

ARLINGTON, VA – A US Food and Drug Administration (FDA) official acknowledged significant regulatory hurdles in the development of products for ultra-rare diseases, necessitating the agency’s recently proposed plausible mechanism framework.

The US Food and Drug Administration (FDA) has notified more than 2,200 medical product manufacturers and researchers to disclose clinical trial results as required by law. The agency said it is part of its risk-based efforts to encourage relevant parties to act before it potentially decides to take regulatory action.

The International Council on Harmonization (ICH) E22 guideline should incorporate caregiver feedback, according to responses submitted by industry groups and manufacturers to a US Food and Drug Administration public consultation.

Many of the bispecific antibodies (BsAbs) approved by global regulators have yet to demonstrate robust clinical benefit beyond surrogate endpoints that led to their initial approval, according to research published in BioDrugs.

US Food and Drug Administration (FDA) officials credited recent advancements in regulatory science and flexibilities with enabling growth in the cell and gene therapy sector during a meeting on Thursday; however, a cell therapy expert said there is still reluctance from FDA and industry to enroll pediatric patients in clinical trials for such treatments.

In the latest tranche of published warning letters, the US Food and Drug Administration (FDA) has continued to go after drugmakers for marketing glucagon-like peptide-1 (GLP-1) receptor agonists and similar medications without regulatory approval. It also issued other warning letters for current good manufacturing practices (CGMP) violations and failing to adhere to clinical trial protocols.

The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative efficacy studies.

Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new approach methodology (NAM) using virtual control groups (VCG) in dose range finding studies that reduce the need for concurrent control groups that use animals.