Regulatory Affairs Professionals Society

FDA seeks feedback on framework for regulating GenAI devices

The US Food and Drug Administration (FDA) is seeking feedback on a competency-based approach to regulating medical devices ...
Regulatory Affairs Professionals Society

Asia-Pacific Roundup: TGA seeks feedback on automated decision making for changes to listed medicines

Australia’s Therapeutic Goods Administration (TGA) has started a consultation into proposed changes to support automated ...
Regulatory Affairs Professionals Society

Recon: FDA clears Roche, Lilly Alzheimer’s blood tests; Regenxbio gene therapy trial halted by FDA again

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Regulatory Affairs Professionals Society

Therapeutic equivalence: FDA finalizes guidance on TE evaluations

The US Food and Drug Administration (FDA) on Monday finalized guidance on its approach to making therapeutic equivalence (TE) ...
RAPS

EMA issues updated guidance on shortage prevention plans ahead of legal deadline

The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.
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This Week at FDA: Inspection reorg, acting CBER chief eyes IND reforms, and more

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, ...
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Euro Roundup: EMA seeks feedback on streamlining drug development for life-threatening diseases

The European Medicines Agency (EMA) is running a consultation into plans to streamline the nonclinical development of treatments for severely debilitating or life-threatening diseases. EMA outlined ...
Regulatory Affairs Professionals Society

FDA finalizes Q&A guidance on developing cell and gene therapies

The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to ...
Regulatory Affairs Professionals Society

Recon: FDA approves Ultragenyx gene therapy for glycogen storage disorder; Overton faces confirmation challenges

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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MDUFA VI deal promises to boost domestic priorities, review consistency

AdvaMed's Zach Rothstein (left) and MDMA's Mark Leahey (right) at FDA headquarters in Silver Spring, MD. (Source: FDA) US Food and Drug Administration (FDA) officials said the next iteration of the ...
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FDA unveils FY 2027 user fee rates

Based on what was agreed to under the Biosimilar User Fee Amendments (BsUFA III), FDA estimated that its base revenue from the program for FY 2027 needs to bring in $58,926,749 before being adjusted ...
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Recon: Lilly to broaden expanded access for unapproved obesity drug; Jazz to withdraw second-line SCLC indication for Zepzelca

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...