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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 ...
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FDA official: Clinical, CMC teams should be on the same page when developing CGTs

WASHINGTON @ Denise Gavin, the director of the Office of Gene Therapy at the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), emphasized that clinical ...
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Euro Roundup: Commission acts to streamline lifecycle management of medicines

The European Commission has published guidelines intended to give companies more flexibility when modifying and updating their marketing authorizations.
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Recon: RFK Jr. launches review of mifepristone; FDA approves Lilly’s advanced breast cancer drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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FDA posts more than 100 warning and untitled letters in ad crackdown

The US Food and Drug Administration (FDA) has published scores of warning letters, most of them to companies for marketing and advertising compounded versions of glucagon-like Peptide-1 (GLP-1) ...
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MHRA to move forward with medical device reliance plans

The UK Medicines and Healthcare products Regulatory Agency (MHRA) plans to propose an indefinite recognition of CE-marked medical devices and new pathways to get devices on the market that have ...
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Industry suggests changes to FDA’s CMC readiness pilot

Officials from the US Food and Drug Administration (FDA) and representatives from the pharmaceutical industry shared insights on the agency@s Chemistry, Manufacturing, and Controls (CMC) Development ...
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Asia-Pacific Roundup: India unveils pharmacovigilance awareness, reporting initiatives

As a part of the effort, IPC created a short film on PvPI, a pharmacovigilance comic published in multiple vernacular languages to enhance public awareness, and a new online reporting platform ...
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Safety labeling: FDA proposes updated guidance on postmarket changes

The US Food and Drug Administration (FDA) published a draft guidance detailing what safety information drug and biologic companies should include in their labeling if they detect serious safety issues ...
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FDA cracks down on drugs ads, promises to end adequate provision ‘loophole’

The US Food and Drug Administration (FDA) on Tuesday announced plans to ramp up enforcement against @misleading@ prescription drug advertisements and to end a longstanding regulation that allows drug ...
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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 ...
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FDA finalizes feedback processes for combo products

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