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The Professional Network for Healthcare Experts
EMA opens consultation on new guideline for gastrointestinal drug-interaction studies
The European Medicines Agency has opened consultation on a draft guideline addressing the design and interpretation of studies assessing drug absorption interactions within the gastrointestinal tract.
nuaxia
Sep 162 min read
FDA pushes faster generic drug development with 55 new product-specific guidances
The latest regulatory package is intended to reduce uncertainty, development costs and delays for generic manufacturers as the US government increases pressure to bring lower-cost medicines to patients more quickly.
nuaxia
Aug 282 min read
FDA finalises clinical investigation guidance for psychedelic drug development
The guidance gives sponsors clearer recommendations for addressing trial design, safety monitoring, abuse potential and the operational challenges associated with hallucinogenic drug effects.
nuaxia
Jul 303 min read
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