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FDA keeps pressure on OTC drugs, bulk products. (Blood/Biologics).: An article from: Validation Times
🇺🇸 United States
FDA keeps pressure on OTC drugs, bulk products. (Blood/Biol…
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INSPECTION LOG.(Food and Drug Administration's Freedom of Information Log)(Brief Article)(Directory): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(Food and Drug Administration's Freedom…
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CBER says firm's activator kit exceeds scope of the pharmacy practice.(Human drugs/Biologics): An article from: Validation Times
🇺🇸 United States
CBER says firm's activator kit exceeds scope of the ph…
By: Dawn Gould
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Preconfigured SAP systems seen speeding validation (1).(sampling and analysis plan)(Brief Article): An article from: Validation Times
🇺🇸 United States
Preconfigured SAP systems seen speeding validation (1).(sam…
By: Peter Dechnik
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Validation specs should be drafted early, with aid of architects, engineers. (Renovations).: An article from: Validation Times
🇺🇸 United States
Validation specs should be drafted early, with aid of archi…
By: Elisa Ludwig
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Failure to tell IRB of 4 deaths leads to 483s.(Institutional Review Board, Michael Jacoby, Mercy Ruan Neurology Clinic): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Failure to tell IRB of 4 deaths leads to 483s.(Institutiona…
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Chemrite, Fabre audits show GMP dearth at OTC drug firms.(OTC )(Brief Article): An article from: Validation Times
🇺🇸 United States
Chemrite, Fabre audits show GMP dearth at OTC drug firms.(O…
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INSPECTION LOG.(inspection documents requested under Freedom of Information Act)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(inspection documents requested under Freedo…
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Part 11 faults with lab equipment lift FDA concerns.(safety and security in pharmaceutical computer systems)(Brief Article): An article from: Validation Times
🇺🇸 United States
Part 11 faults with lab equipment lift FDA concerns.(safety…
By: Peter Dechnik
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Canada aims for 7-day approval for Phase I trials; rules redefine sponsors.(Canada): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Canada aims for 7-day approval for Phase I trials; rules re…
By: Tamra Sami
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Ensuring contractor lab validation falls to OTC drug maker, FDA concludes.(Burnham Laboratories): An article from: Validation Times
🇺🇸 United States
Ensuring contractor lab validation falls to OTC drug maker,…
By: Wallace Witkowski
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Medical journals' rule, IND reminders boosts Clinicaltrials.gov registrations.(Investigational New Drug): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Medical journals' rule, IND reminders boosts Clinicalt…
By: Diane West
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PPD Development receives 7-item 483 for stability, validation issues.: An article from: Inspection Monitor
🇺🇸 United States
PPD Development receives 7-item 483 for stability, validati…
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Questionable OOS handling at American Pharm Partners raises eyebrows at FDA. (Human Drugs).: An article from: Inspection Monitor
🇺🇸 United States
Questionable OOS handling at American Pharm Partners raises…
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INSPECTION LOG.(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(Brief Article): An article from: Inspection…
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INSPECTION LOG.(requests for inspection reports)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(requests for inspection reports)(Brief Arti…
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BPD rule yields 35% jump in biologic adverse reports; labeling a leading cause.: An article from: Warning Letter Bulletin
🇺🇸 United States
BPD rule yields 35% jump in biologic adverse reports; label…
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Vaccine shortages abated, but FDA, CDC concerned about '01 outlook. (Food and Drug Administration, Centers for Disease Control and Prevention).(Brief Article): An article from: Validation Times
🇺🇸 United States
Vaccine shortages abated, but FDA, CDC concerned about …
By: Ken Reid
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Wyeth hit with 54-item 483 for OOS results, faulty aseptic results, HVAC.(Human drugs): An article from: Validation Times
🇺🇸 United States
Wyeth hit with 54-item 483 for OOS results, faulty aseptic …
By: Joseph Pickett
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FDA envisions slight drop in audits for biologics, drugs in FY '06; device inspections to stay even.: An article from: Inspection Monitor
🇺🇸 United States
FDA envisions slight drop in audits for biologics, drugs in…
By: Joseph Pickett
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New test method, training follow Kendall complaint.(inspection of Kendall Company's catheters and ventilation/tracheal tube)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
New test method, training follow Kendall complaint.(inspect…
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With sunsetting of 209 standard, question is if FDA will accept ISO 14644.(Brief Article): An article from: Validation Times
🇺🇸 United States
With sunsetting of 209 standard, question is if FDA will ac…
By: Ken Reid
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3M's nod on 40-item 483 smooths future audits.(3M Pharmaceuticals)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
3M's nod on 40-item 483 smooths future audits.(3M Phar…
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Food safety inspections may limit BiMo, foreign : Pre-approval NDA audits to get big cuts.(bioresearch monitoring)(new and abbreviated drug ... Article): An article from: Inspection Monitor
🇺🇸 United States
Food safety inspections may limit BiMo, foreign : Pre-appro…
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Inspection log.(from Food and Drug Administration in compliance with Freedom of Information Act)(Public Notice): An article from: Inspection Monitor
🇺🇸 United States
Inspection log.(from Food and Drug Administration in compli…
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'Comparability protocols' touted as time-saving tools.(United States Food and Drug Administration on biologics industry)(Brief Article): An article from: Validation Times
🇺🇸 United States
'Comparability protocols' touted as time-saving t…
By: Ellen Beck
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Contract designer hit for having no design controls.(Brief Article): An article from: Validation Times
🇺🇸 United States
Contract designer hit for having no design controls.(Brief …
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Industry seen liable for criminal, civil charges if CROs, investigators err.(contract research organization)(Brief Article): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Industry seen liable for criminal, civil charges if CROs, i…
By: Ellen Beck
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'Pharmaceutical Inspectorate' and team inspections created for human, animal drugs: all Part 11 guidance, CPG revoked.: An article from: Inspection Monitor
🇺🇸 United States
'Pharmaceutical Inspectorate' and team inspection…
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2 warning letters, two 483s bar Ansell glove imports.(inspection of Ansell Medical)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
2 warning letters, two 483s bar Ansell glove imports.(inspe…
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483/EIR update.: An article from: Inspection Monitor
🇺🇸 United States
483/EIR update.: An article from: Inspection Monitor
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12-item 483 for CI highlights examples of poor trial site oversight.(Clinical investigators): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
12-item 483 for CI highlights examples of poor trial site o…
By: Joseph Pickett
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