Joanne S. Eglovitch

LONG BEACH, CA @ The US Food and Drug Administration@s (FDA) Center for Biologics Evaluation and Research (CBER) saw a decrease in the number of clinical holds placed on biological products in recent years, thanks to early engagement with sponsors and other efforts by the center. @

LONG BEACH, CA @ US Food and Drug Administration (FDA) officials shared an update on the status and progress of two pilot programs that aim to promote the development of innovative medicines at RAPS Convergence 2024. One addresses the development of treatments for rare diseases, while the other is intended to speed the development of therapies that address an unmet medical need. @

The US Food and Drug Administration@s (FDA) new Rare Disease Innovation Hub will serve as a main point of focal point for the rare disease community to raise issues related to developing drugs in this space and will take a different approach in reviewing these drugs compared to the center for excellence model in the center for drugs.

The US Food and Drug Administration (FDA) on Tuesday finalized a guidance to assist sponsors and clinical investigators comply with the electronic records regulations for clinical trials under 21 CFR Part 11.

Preventing diethylene glycol (DEG) or ethylene glycol (EG) contaminants from slipping into drugs and ensuring that ophthalmic drug manufacturers adequately test their sterile products are two priorities for the US Food and Drugs Administration (FDA) manufacturing quality teams. @

The US Food and Drug Administration (FDA) announced on Wednesday that it will give firms additional time before it begins enforcing its enhanced distribution security requirements under the Drug Supply Chain Security Act (DSCSA), heeding calls from industry and lawmakers to delay certain aspects of the law@s implementation to avoid potential shortages. @

A recent survey commissioned by the International Council for Harmonisation (ICH) found that the adoption of its guidelines has increased among its non-founding members and observers since 2019. In addition, there is a @good alignment@ between companies and regulators on their adherence to the guidelines. @

The European Medicines Agency (EMA) last week released a new concept paper for a future guideline on the clinical evaluation of therapeutic radiopharmaceuticals (tRPs) for treating cancer to address the growing number of requests for scientific advice for these products.

BARCELONA @ Manufacturers of medical devices with artificial intelligence (AI) capabilities should be aware that they may be subject to additional requirements governing quality management systems and technical documentation under the recently adopted Artificial Intelligence Act if the devices are considered high-risk under the act.

BARCELONA @ Manufacturers should ensure that their clinical evaluations for high-risk devices include a clear statement of the device@s benefit and a well-developed postmarket surveillance plan to ensure smooth notified body review of their submissions, asserted Susan Partridge, clinical regulatory lead at BSI, at the RAPS European Clinical, Risk, and Postmarket Surveillance Conference on 23 October. @