FDA process analytical technology guidance

FDA will publish draft guidance on process analytical technology in September.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 The draft guidance is expected to draw from the agency's existing guidance on 21 CFR Part 11 electronic record/electronic signatures (1"The Pink Sheet" Oct. 28, 2002, p. 30)...