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Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent draft guidance on the development of a plausible mechanism framework for individualized therapies to treat rare diseases.

Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also known as forever chemicals.

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.

The European Medicines Agency (EMA) has finalized a document with recommendations on using the European Medicines Regulatory Network (EMRN) Data Quality Framework (DQF) when submitting premarket applications that include real-world data.

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 US Food and Drug Administration (FDA) has warned an oncology drug company for repeatedly overstating the efficacy of its drug in advertisements while failing to adequately disclose the associated risks. The agency also issued several warning letters to companies for violations of current good manufacturing practices (CGMP) and for marketing products for non-approved indications.

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 Center for Science in the Public Interest has published a set of recommendations in JAMA they say would help improve transparency at the US Food and Drug Administration (FDA).

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance on how marketing applicants can use non-animal data in their applications. The move comes on the heels of a similar initiative by the US Food and Drug Administration (FDA) to reduce the need for animal testing in drug development.

Amid discussions to reauthorize the US Food and Drug Administration's (FDA) Prescription Drug User Fee Act (PDUFA VIII) program on 19 February, industry representatives questioned increased PDUFA payroll spending in FY 2025 – despite staff cuts that year – and both sides reached agreement on continuing the Rare Disease Endpoint (RDEA) program.

The US Government Accountability Office (GAO) says that the US Food and Drug Administration (FDA) should issue a timeline for finalizing a guidance on handling potential financial conflicts of interest for members of its advisory committees. The agency said the move would provide the public with greater transparency and assurance that it is taking significant mitigating steps to prevent conflicts of interest in regulatory decision-making.

The European Medicines Agency (EMA) has provided guidance to help manufacturers adhere to good manufacturing practices (GMPs) when using three-dimensional (3D) printing technology, also known as additive manufacturing, in the production of solid oral dosage forms.

Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug User Fee Amendments (GDUFA) program. The topics addressed during the meeting included drug master files (DMFs), internal consultations, and imminent actions.

Top European officials said they are optimistic that amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will be enacted quickly, but the amendments must also comply with legislative requirements, which will take several months.

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.

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) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug development. The agency is urging companies to adopt new approach methodologies (NAMs), incorporating in vitro human-based systems, such as organs-on-chips and in silico modeling, to assess drug safety.

Industry groups and drugmakers want the US Food and Drug Administration (FDA) to explicitly clarify that Bayesian statistical methods can be used for products beyond those intended for children and rare diseases. They also asked for additional case examples in the guidance to clarify the agency's expectations.

The US Food and Drug Administration (FDA) has finalized guidance for manufacturers on using physicochemical and structural (Q3) characterization studies to establish bioequivalence in abbreviated new drug applications (ANDAs) for topical medications.

The US Food and Drug Administration (FDA) and the medtech industry have reached agreement on several key areas as they negotiate the next iteration of the Medical Device User Fee Amendments (MDUFA VI) program. Among the areas of agreement is using the next round of fees to fund upgrades to the agency's IT systems and changes to its de novo and pre-submission programs.