In Brief

Bayer buys herbal firm; NBTY notes bright spots, hires international leader; Neptune prepares to rebuild; P&G suit targets CAO’s tooth whiteners; CSPI supports restricting St. John’s wort; Coppertone schools parents; Hillary Clinton will speak at NACDS Total Store Expo.

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

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Misconstruing Single-Arm Study Data Lands BMS In Trouble With US FDA

 

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HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

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Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.