Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Study: Patient, consumer reps at FDA adcomms increasingly hold ties to pharma-backed advocacy groups
At some advisory committee meetings, more than half of patient and consumer representatives who attended had connections to ...
A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to ...
Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic ...
The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet ...
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 ...
The US Food and Drug Administration (FDA) is seeking public input on how to design early-phase clinical trials to evaluate ...
The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and ...
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 ...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring ...
Over the last 15 years, there has been an uptick in the number of patents associated with small-molecule drugs approved by the US Food and Drug Administration (FDA), with a majority of the increase ...
The World Health Organization (WHO) has issued an updated draft guideline to assist manufacturers establish an effective quality risk management (QRM) system and to help regulators in planning their ...
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