Fetal Research Requires Maternal Consent Only, HHS Final Rule Says

HHS-supported research involving pregnant women or fetuses prior to delivery requires only maternal consent under an HHS final rule, published in the Federal Register Jan. 17.

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‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 

PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
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The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Valneva Expects UK And France to Lift Ixchiq Age Restriction Following EMA Decision

 

Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.