RAPS

Euro Roundup: Joint HMA-EMA group starts consultation into priorities for AI in research and regulation

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are running a survey to inform research priorities for the use of artificial intelligence in the development and ...
RAPS

FDA draft guidance covers low-level light therapy devices

The US Food and Drug Administration (FDA) has published a draft guidance for low-level light therapy (LLLT) devices, or photobiomodulation (PBM) devices, which are typically used for aesthetic or ...
RAPS

Shutdown: FDA will not accept submissions until funding resumes

The US Food and Drug Administration (FDA) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the ...
RAPS

Onshoring: Drugmakers seek enhancements to FDA’s PreCheck program

During a public meeting on onshoring the production of drugs in the US on Tuesday, stakeholders called for improvements to the US Food and Drug Administration@s (FDA) recently launched PreCheck ...
RAPS

FDA official updates on advancing RWE program, lists common reasons for rejection

Some of the main reasons the US Food and Drug Administration (FDA) rejects applicants from participating in its Advancing Real-World Evidence (RWE) Program include concerns that proposed real-world ...
RAPS

FDA finalizes device production and quality system software guidance

@The US Food and Drug Administration@s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...
RAPS

This Week: FDA revokes LDT rule, Monarez warns about vaccine policies, Kennedy called to defend his decisions

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 ...
RAPS

FDA to publish CRLs ‘promptly’ as drugs are rejected

The US Food and Drug Administration (FDA) on Thursday announced it will publish complete response letters (CRLs) detailing the reasons for a product@s rejection soon after they are issued to ...
RAPS

CBER/OTP clinical hold pilot assessment for cellular and gene therapy INDs

The Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA) initiated a six-month pilot in July 2023 to reduce ...
RAPS

FDA unveils FY 2026 user fee rates

The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2026 across its prescription drug, generic drug, biosimilar, and medical device programs. The rates are ...
RAPS

7-year FDA review finds improved GCP compliance

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
RAPS

EMA: Drug repurposing efforts saw limited success during pilot

The European Medicines Agency (EMA) said researchers working to repurpose out-of-patent drugs face significant challenges, such as interpreting the available data to support a regulatory application ...