Articles from Women's Health Letter (February 1, 2006)

Title	Author	Type	Words
'Critical path' conflict-of-interest requirements needed before FDA partners with outside world on PAT activities: CDER deputy.	Ken Reid,		417
10 firms piloting PAT, QbD, including 2 generics makers; March 2006 deadline imposed for participation.	Faden, Mike; Reid, Ken		549
10 FTEs to be assigned to PADE inspections in FY '06: CDER official.	Pickett, Joseph		378
ASTM E55 issues new draft of pharma standard, next ballot set for March.	Reid, Ken		733
Avid Bioservices advised to use qualified, validated equipment; Part 11 also mentioned.	Pickett, Joseph		791
Boston Scientific hit with warning letter for three separate facilities.			418
FDA continues to cite Part 11 violations in 483 for Takeda.	Pickett, Joseph		609
Gambro Dasco SpA cited for CAPAs.			140
Guidant cited for Part 11 issues in 15-item 483; J&J merger postponed.	Pickett, Joseph		533
National Genetics Institute cited for software validation flaws.			294
Quality audits and validation of sterilized products lacking for Haemacure.			98
Schering-Plough gets 6-item 483 for water system sanitization and maintenance.	Pickett, Joseph		899