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Title	Date	Words
Akorn nets 22-item 483 for validation and quality deviations.	Jul 1, 2008	1827
Discrepancy review flaws nets Altaire 4-item 483.	Jul 1, 2008	315
Quality control problems net Elge 14-item 483.	Jul 1, 2008	1294
Physio Control hit with 32-item 483 for design verification and software flaws.	Jul 1, 2008	1124
Burden of proof of safety must fall on drug manufacturers: Woodcock.	May 1, 2008	427
Inspector finds Changzhou testing equipment 'unsuitable,' but MOU didn't help FDA get information.	May 1, 2008	1270
Dingell discussion draft requires inspection prior to importing any drug or device to U.S.; FDA disagrees.	May 1, 2008	1083
FDA policy, IT limits failed in Baxter audit of Changzhou SPL.	May 1, 2008	653
Berna Biotech cited for faulty media fill procedures.	May 1, 2008	837
Pulse Biomedical hit with 6-item 483 for design change flaws.	May 1, 2008	889
Quality SOPs trip up Sanofi Pasteur.	May 1, 2008	426
FDA needs $70 million more per year to inspect foreign drug plants: Commissioner von Eschenbach.	Apr 1, 2008	1062
Legislation could be most significant change in drug law since 1962: CDER's Throckmorton.	Apr 1, 2008	697
Hazard analysis simple, powerful method to identify risk, says Chatterjee.	Apr 1, 2008	843
CBER in 2008 to focus on improving manufacturing and product quality, CBER director Goodman says.	Apr 1, 2008	481
AvTech Laboratories receives clean audit.	Apr 1, 2008	372
ArthoCare Corporation clears FDA audit.	Apr 1, 2008	212
7-item 483 to device firm for acceptance /rejection of product.	Apr 1, 2008	409
Spinal USA hit with 14-item 483 for faulty design plan review.	Apr 1, 2008	585
Sterilmed passes FDA inspection.	Apr 1, 2008	262
FDAAA 2007 has impact on AREA and BPCA.	Mar 1, 2008	317
$225 million authorized under FDAAA 2007 Act for PDUFA user fees.	Mar 1, 2008	316
REMS frequency seen increasing under FDAAA 2007, former chief counsel says.	Mar 1, 2008	497
BASF receives 483 for unvalidated computer systems.	Mar 1, 2008	475
Biozyme gets 3-item 483 for inadequate investigations of API validation batches.	Mar 1, 2008	333
Changzhou fails to remove impurities, check OOS results.	Mar 1, 2008	525
Eli Lilly-Clinton Labs receives hefty EIR, but no 483 issued.	Mar 1, 2008	1318
Gebauer tripped on CAPAs and environmental condition procedures.	Mar 1, 2008	660
Future drug pre-approval inspections to focus on better communication between FDA divisions.	Feb 1, 2008	356
Individuals always named in consent decrees; practice strongly founded in case law.	Feb 1, 2008	655
Civil monetary penalties used when seizure, injunction, prosecution are inadequate.	Feb 1, 2008	296
CPG for un-cleared medicines focuses on safety risks, lack of effectiveness, fraud.	Feb 1, 2008	400
116 medical device warning letters issued in FY '07 with focus on GMP, QS.	Feb 1, 2008	459
IVX slapped with 15-item 483 for contamination procedures.	Feb 1, 2008	1062
ADE inspections drop from fiscal '06, but 150+ ADE inspections expected in FY 2008: Krueger.	Jan 1, 2008	549
ERA in EU required for previously registered APIs, but negative result doesn't mean marketing authorization denial.	Jan 1, 2008	576
New China agreements mark important steps in boosting safety of imported active pharmaceutical ingredients.	Dec 1, 2007	1190
Electronic signature policy key to submitting properly formatted eCTD.	Dec 1, 2007	1373
USP moves toward a universal standard for Protein A.	Nov 1, 2007	440
Many methods of protein aggregation used together make complete picture.	Nov 1, 2007	576
Nature/history of production cell line key to justify virus detection assay omissions.	Nov 1, 2007	623
GMP audits in India nearly double in FY '07, but inspections in China drop, CDER chief notes.	Oct 1, 2007	433
Sterility assurance submission must be well organized, FDAer says.	Oct 1, 2007	425
Clear and complete QOS yields shorter reviewer time.	Oct 1, 2007	528
CTD electronic format recommended for ANDAs to support QBR.	Oct 1, 2007	444
With recalls numbering 975 to date, FDA relying on ICH Q10 for QbD progress.	Sep 1, 2007	894
7 CMC guidance documents withdrawn for non-conformity with FDA's GMP initiative.	Sep 1, 2007	402
GMP audit imminent after 6-year inspection gap, states 2007 risk-based model: Gardner.	Sep 1, 2007	497
Risk-based auditing nets 6% decrease in follow up FDA audits in same year.	Sep 1, 2007	547
Dingell bill would boost food and drug inspections in FY 2008-2012, including APIs sourced from overseas.	Aug 1, 2007	825
Warning letters focus on CAPAs, senior management inattention to quality.	Aug 1, 2007	722
Task force recommends new guidance on quality, risk assessment, safety of nanoscale materials.	Jul 1, 2007	730
Lack of sterility assurance and non-sterility top drug recall reasons for FY '06: Famulare.	Jun 1, 2007	422
PQLI project by ISPE to tackle implementation of QbD, creation of reference materials.	Jun 1, 2007	417
CDER inspector says firms must manufacture non-pencillin beta-lactam drugs in separate facility.	Jun 1, 2007	579
Dirty equipment holding time high risk with water left on equipment: Pfizer exec.	Jun 1, 2007	602
PQLI design space session recommends determining critical quality attributes first.	Jun 1, 2007	447
Parametric Release CPG to be revised as sterile drug recalls are on the rise.	May 1, 2007	729
New paradigm benefits include regulatory flexibility, fewer lot rejects, recalls: FDA's Cherney.	May 1, 2007	737
Failure to qualify off-the-shelf disinfectants becomes leading 483 item.	May 1, 2007	395
Change within design space is not a regulatory change: Genentech official.	May 1, 2007	516
Total CDER inspections decreased slightly in FY '06, CDRH audits hold steady.	Apr 1, 2007	847
Experimental design has advantages in biopharm: Nayar.	Apr 1, 2007	594
ICH Q3C guidance reduces solvent use to enhance patient safety, Baxter executive says.	Apr 1, 2007	827
Actavis Totowa nets warning for QC, cleaning validation.	Mar 1, 2007	963
Edwards Life Sciences warned for quality data and CAPAs.	Mar 1, 2007	394
Fisher & Paykel written up for quality problems.	Mar 1, 2007	381
Failing to validate design nets warning for GE Healthcare.	Mar 1, 2007	342
Surgical drape maker cited for CAPAs validated process procedures.	Mar 1, 2007	304
Design and development plan flaws net warning for Newport Medical.	Mar 1, 2007	325
Rymed warned for lack of control of process parameters.	Mar 1, 2007	442
PAT is 'emblematic' of new pharmaceutical thinking under 'Critical Path,' Woodcock tells IFPAC.	Feb 1, 2007	569
Validating consumer COTS lab instruments results in cost and time savings, better than GAMP: Amgen.	Feb 1, 2007	717
Documentation, knowing what you want to achieve key in validating hardware.	Feb 1, 2007	421
PAT used at Pfizer to improve product knowledge, remove variability from process.	Feb 1, 2007	412
Change control and calibration net 4-item 483 for Chemtura.	Feb 1, 2007	240
Part 11 rears its head in Draxis Pharma 3-item 483.	Feb 1, 2007	1334
Nine-item 483 for Positron for calibration and quality audit problems.	Feb 1, 2007	899
CAPAs and quality audits cited for Talon Acrylics in 3-item 483.	Feb 1, 2007	674
Bell-More warned for control system failures.	Feb 1, 2007	883
Omnicare/Heartland cited for "serious" violations in quality control systems.	Feb 1, 2007	1226
DreamWest receives warning letter for failure to validate manufacturing processes.	Feb 1, 2007	329
Encore Medical slapped with warning for CAPAs, spec change procedures.	Feb 1, 2007	562
CAPAs and validation flaws trip up Levitronix.	Feb 1, 2007	655
PhRMA supports move to all-electronic drug applications; questions arise at hearing about re-visiting Part 11 guidance.	Dec 1, 2006	625
Drug manufacturer slapped with 5-item 483 for procedures to prevent contamination.	Dec 1, 2006	485
CareFore hit with 10-item 483 for lack of design and development plan.	Dec 1, 2006	393
Utah Medical Products receives two 483s; lawsuit ensues.	Dec 1, 2006	1337
Identity testing, other GMP issues snare Benchmark Medical.	Dec 1, 2006	268
Direct dispensing cited for labeling issues.	Dec 1, 2006	367
Unapproved ingredient nets letter for Health Dimensions.	Dec 1, 2006	158
Unnamed Italian device firm warned for misbranding.	Dec 1, 2006	195
Dupaco issued warning letter citing CAPAs and failure to meet specs.	Dec 1, 2006	180
Gyrus written up for nonconforming procedures.	Dec 1, 2006	241
M & S Acquisition slapped with letter for quality problems and validation.	Dec 1, 2006	282
Perkins Electronics receives letter for device design validation.	Dec 1, 2006	408
Failure to verify products meet specs nets letter for Skytron.	Dec 1, 2006	166
Trionix Research Laboratory hit with warning letter for CAPAs.	Dec 1, 2006	275
SOCMA and EFCG call for level playing field for domestic and foreign API manufacturers.	Nov 1, 2006	698
Sterility assurance submission should have clear terminal sterilization or aseptic process, says OGD's Sweeney.	Nov 1, 2006	559