FDA will publish draft guidance on process analytical technology in September. "I hope you'll all have a chance in September...to read our new guidance document that we'll be releasing on the use of process analytical technology in making possible innovations in drug manufacturing and quality assurance," FDA Commissioner McClellan tells PQRI workshop Aug. 5. The draft guidance is expected to draw from the agency's existing guidance on 21 CFR Part 11 electronic record/electronic signatures (1"The Pink Sheet" Oct. 28, 2002, p. 30)...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
