Browse Reid, Ken

1-65 out of 65 article(s)

Title	Type	Date	Words
Few in industry filing applications with nanotech materials, though FDAers ponder if better 'in-spec' products could be made.		Feb 1, 2009	358
Smaller particles in largely unregulated cosmetics concern FDA for potential to leach under patient skin.		Feb 1, 2009	1121
IPEC group examining applying principles of validation to non-actives.		Sep 1, 2007	541
Inspectors to spend more time watching processes under new compliance program; parametric release CPG in offing, too.		Jun 1, 2006	585
483 citations for environmental monitoring down; not even in top 30.		Jun 1, 2006	443
Experts disagree on allowing handicapped personnel in firms' clean rooms.		Jun 1, 2006	423
ASTM E55 issues new draft of pharma standard, next ballot set for March.		Feb 1, 2006	733
Acambis executive urges agreements when contracting out most QA functions, but more specifics needed.		Dec 1, 2005	822
FDA hopes to emulate pre-IND, pre-NDA meetings for CMC reviews; workshop slated for fall, pilot to follow.		Jun 1, 2005	924
FDA sees guidance on GMPs for IND products by year's end, focusing on risk, examples of what applies in certain phases.		Apr 1, 2005	722
Several EU guides on horizon for viral clearance, GMPs in clinicals; PQR1 to examine viral safety.		Apr 1, 2005	529
Moving from cell-based to binding assays advisable, but expensive, ex-FDAer says.		Apr 1, 2005	584
CDER's Nasr sees reviewers joining in on audits, MAPP template for CMC reviews.		Mar 1, 2005	426
Facets of drug GMPs to be redone; FDA pushes ICH quality initiatives, industry to offer validation paper.		Sep 1, 2004	572
PAT not specifically mentioned in CPG to waive 3-batch validation if firms use 'advanced science,' engineering principles.		Jun 1, 2004	675
FDA won't issue CMC guidance under GMP Initiative, may try to eliminate supplements, move to 'quality assessments'.		Jun 1, 2004	470
Maryland GMP facility to offer training to FDA inspectors, industry.		May 1, 2004	360
'Like-for-like' changes need not come under GMP change requirements, but open changes draw FDA ire.		Apr 1, 2004	393
Drug, vaccine, biologic firms have two years to provide new bar coding on labels; medical devices, bulk drugs seen next.		Feb 1, 2004	995
Contract manufacturer says $1 million can be saved annually through online bioburden testing.		Jan 1, 2004	397
USP may adopt chapter on ancillary product validation; is USP helping 'generic biologics'?		Nov 1, 2003	1431
FDA could second-guess ranking of CAPAs, expert says.		Nov 1, 2003	262
Despite variability, FDAer says bioassay still needed in validation; USP to revise Chapter 111.		Nov 1, 2003	355
"Critical" data key to determining risk-based Part 11 compliance plan: FDA.		Oct 1, 2003	622
3 to 9 retests for OOS deemed acceptable to FDA, former CDER official says.		Sep 1, 2003	691
FDA, EU expecting manufacturers to use CAPA to halt OOS, determine 'root cause'.		Sep 1, 2003	673
Food and Drug Administration may re-issue some revoked Part 11 guidance; validation guide still has merit.		Jun 1, 2003	478
PAT beneficial to biologics, and biotech, but new GMP rules not needed, Zoon says.	Interview	Jun 1, 2003	529
FDA admits not comparing drug GMPs in drafting supplement rules; some standards stiffer than for OTC drugs. (Supplements).		Apr 1, 2003	828
PAT rollout to have technical guidance, possibly derived from ASTM, CDRH. (Process analytical technology).		Jan 1, 2003	896
Drug makers lag behind other industries in moving to PAT, but Glaxo U.K. using acoustic monitoring. (Monitoring/validation).		Jan 1, 2003	923
Drug chemistry chief only eyeing submission data for complex PAT; comparability protocol seen as alternative. (CMC).		Jan 1, 2003	439
Lilly scientist sees vast use of PAT and FDA acceptance, too. (PAT Tools).		Jan 1, 2003	817
Commissioner-designate has little compliance/ enforcement background; Crawford experience greater, but will he stay on? (FDA Management).		Sep 1, 2002	1190
CBER official sees need in Phase II, but new EU Annex 13 may differ. (Cleaning validation).		Sep 1, 2002	762
Benefits debated for pre-approval, or post-approval; can PAT help 90% of oral solids? (Process analytical technology).		Jun 1, 2002	1304
Part 11 deems sample request signatures as records; systems not Part 11-exempt.	Brief Article	May 1, 2002	625
ISO standard for cleanroom operations issued; could offer guidance on gowning, cleaning. (Cleanrooms).		Mar 1, 2002	285
With sunsetting of 209 standard, question is if FDA will accept ISO 14644.	Brief Article	Feb 1, 2002	609
Warning letter review by Chief Counsel may slow enforcement.	Brief Article	Dec 1, 2001	939
Validation still needed despite new technology; monoclonal guide can help.	Brief Article	Oct 1, 2001	746
EU stresses in-process controls, but no post-approval audits in store.	Brief Article	Oct 1, 2001	520
Part 11 Guide Seeks OTS, Internet Validation.	Brief Article	Sep 1, 2001	632
Quality planning needs several facets, exec says.	Brief Article	Jun 1, 2001	498
Inspectors eyeing reports after approval; FDAer details what they should contain.		Jan 1, 2001	1389
Vaccine shortages abated, but FDA, CDC concerned about '01 outlook. (Food and Drug Administration, Centers for Disease Control and Prevention).	Brief Article	Dec 1, 2000	683
Quality systems - 'Six Sigma' can gel with QS, even 1978 drug GMPs: expert. (good manufacturing practice, Charles Truby).	Brief Article	Dec 1, 2000	483
Quality systems - Risk analysis seen benefitting firms in recall situations.	Brief Article	Oct 1, 2000	574
FDA may ask firms to mail in process data after approval.	Brief Article	Sep 1, 2000	575
'Audit logs' not acceptable under Part 11; audit trail more desirable: Hill.	Brief Article	Sep 1, 2000	440
FDA, drug industry hope PQRI meeting will resolve BUA.	Brief Article	Aug 1, 2000	280
CBER guidance said to be held up by CDER worries.	Brief Article	Jun 1, 2000	293
Validation stops 30% of ANDAs, NDAs in review. (Pre-approval inspections).		May 1, 2000	405
FDA, U.K.'s MCA can go own way on particle size, despite ISO guide.		Apr 1, 2000	787
FDAer suggests giving summary of media fill validation errors. (Media fills).		Feb 1, 2000	428
Partial validation of assays O.K., not total error criterion.		Jan 1, 2000	705
Validation handled better by generics, CROs, FDA finds.		Jan 1, 2000	604
Air sampling before production, once during, is suggested.		Jan 1, 2000	523
Management role becoming key in 'Team Biologics'.	Brief Article	Dec 1, 1999	799
Most revisions in manufacturing, specifications seen as 'major' in guide.	Brief Article	Nov 1, 1999	677
`Family validation' allowed, but not for any 'similar' drug.	Brief Article	Oct 1, 1999	830
Viral safety in biopharmaceutical production to be key in CBER draft.	Brief Article	Sep 1, 1999	749
Panel opposes site-specific data, backs process validation.	Brief Article	Sep 1, 1999	446
Firms advised to follow API guide for finished drugs.	Brief Article	Aug 1, 1999	1066
Inspectors seeking bioburden tests on steam sterilizers.	Brief Article	Jul 1, 1999	592