The first document of a three-part series of ICH guidelines on conducting bioequivalence studies for orally administered immediate-release solid oral dosage forms has been issued for stakeholder consultation.
The International Council for Harmonisation has proposed standardized bioequivalence (BE) study requirements for immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules and granules/powders for oral suspension.
The draft ICH M13A guideline was keenly awaited by generic drug manufacturers, who need to undertake BE assessments for...
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The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
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Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
