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The US Food and Drug Administration (FDA) has finalized guidance on incorporating patient preference information (PPI) for assessing the benefit-risk profile of certain medical devices throughout the total product life cycle.

The Pharmaceutical Research and Manufacturers of America (PhRMA) has stated that the ICH M4Q(R2) involves a significant restructuring of the quality section of the Common Technical Document (CTD), bringing major changes for both the industry and regulators. As such, ICH and regulatory authorities should promote global synchronization of the guideline’s implementation to reduce the need for maintaining dual dossier structures.

The Philippine Food and Drug Administration (FDA) is holding a consultation into plans to update and standardize the contents of the License to Operate (LTO) for pharmaceutical establishments.

There have been a handful of artificial intelligence (AI)-enabled medical devices approved by the US Food and Drug Administration (FDA) over the last decade, and those that were have been limited to a few clinical areas, according to recent research published in JAMA Network Open.

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, FDA said it wants to gather public feedback on the Commissioner's National Priority Voucher program, amid questions about the validity of claims about its speed by FDA Commissioner Marty Makaray.

The European Medicines Agency (EMA) has introduced three features to improve its PRIME scheme for supporting the development of medicines targeting unmet medical needs.

Generative artificial intelligence (AI) tools in clinical practice should have an oversight framework that resembles how human clinicians are trained and certified, with continuous learning, regular assessments, and supervised practice, experts argued in a recent Viewpoint article published in JAMA Health Forum.

India's Central Drugs Standard Control Organization (CDSCO) has introduced draft legislation describing the requirements for informing authorities of manufacturing changes.

The European Medicines Agency (EMA) has published a strategy for implementing international guidelines on managing post-approval safety data.

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the move would modernize adverse event reporting systems and provide more transparency.

The Indian Council of Medical Research (ICMR) has outlined plans to adopt a single ethics committee review mechanism for clinical trials.

The European Medicines Agency (EMA) is seeking feedback on draft guidance about conducting clinical trials during public health emergencies (PHEs).

A majority of cancer survivors surveyed about a hypothetical drug approved by the US Food and Drug Administration (FDA) through a proposed new pathway for diseases with unmet needs appeared less willing to enroll in a clinical trial when a conditionally approved drug is available, and seemed unaware that conditionally approved drugs would have a lower evidentiary requirement than traditionally approved drugs, according to a recent research letter published in JAMA Network Open.

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.

A European Union court has dismissed multiple requests to annul the Urban Wastewater Treatment Directive (UWWTD) because they failed to meet the legal requirements to challenge the law.

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is running a consultation into the rules and guidelines for seeking approval of medicines via the consent by verification pathway.

The European Medicines Agency (EMA) has set out plans to create guidance on myasthenia gravis (MG) clinical trials in a draft concept paper.

The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual facility fees for the first three years for companies that establish manufacturing operations for finished generic drugs or active pharmaceutical ingredients (APIs) in the US during user fee negotiations.

The US Food and Drug Administration's (FDA) increasing reliance on holding expert panels, rather than advisory committees, for external expert advice may violate the Federal Advisory Committee Act (FACA), a pair of experts argued in a recent JAMA Health Forum Viewpoint article.