The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to ...
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The European Medicines Agency (EMA) is holding a consultation about a draft framework intended to cut the time it takes to implement data standards. Working with the Heads of Medicines Agencies (HMA), ...
Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices ...
Using the US Food and Drug Administration’s (FDA) plausible mechanism framework to allow for greater use of causal inference ...
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 Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released a revised guide for inspectors and the pharmaceutical industry outlining the general principles of qualification and validation ...
The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for ...
The use and implementation of new approach methodologies (NAMs) and digital technologies such as artificial intelligence (AI) may help improve the predictability and interpretation of central nervous ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
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