Form FDA 483

Results: 519



#Item
191Clinical research / Pharmacology / Form FDA 483 / Regulatory requirement / Food and Drug Administration / Pharmaceutical sciences / Pharmaceuticals policy

Microsoft PowerPoint - Richardson-PharmaC-HCTP 483 resp 29 DEC2008.ppt

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Source URL: www.fda.gov

Language: English
192Health / Pharmaceutics / Food safety / Clinical research / Quality / Validation / Verification and validation / Influenza vaccine / Form FDA 483 / Pharmaceutical industry / Validity / Pharmaceutical sciences

Memorandum Food and Drug Administration Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality

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Source URL: www.fda.gov

Language: English
193Health / Pharmaceutics / Food safety / Clinical research / Quality / Validation / Verification and validation / Influenza vaccine / Form FDA 483 / Pharmaceutical industry / Validity / Pharmaceutical sciences

Memorandum Food and Drug Administration Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality

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Source URL: www.fda.gov

Language: English
194Medicine / Validity / Pharmacology / Systems engineering / Clinical research / Meningococcal vaccine / Form FDA 483 / Meningococcal disease / Validation / Vaccines / Pharmaceutical sciences / Pharmaceutical industry

Review Memo: BLA, New vaccine for the prevention of disease caused by Neisseria meningitidis serogroups A, C, W-135, and Y

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Source URL: www.fda.gov

Language: English
195Pharmaceutical sciences / Title 21 CFR Part 11 / Form FDA 483 / Center for Drug Evaluation and Research / Center for Food Safety and Applied Nutrition / Center for Devices and Radiological Health / Office of Regulatory Affairs / Center for Biologics Evaluation and Research / Good manufacturing practice / Food and Drug Administration / Medicine / Health

Small Business Guide to FDA

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Source URL: www.fda.gov

Language: English
196Pharmaceutical industry / Cleaning / Cleanroom software engineering / Software quality / Validation / Aseptic processing / Form FDA 483 / Packaging and labeling / Review / Technology / Business / Science

BLA[removed]Resubmission CMC Review of Complete Response letter items (including 483 items) and additional information not contained in original submission azficel-T (LAVIVĀ®) Fibrocell Technologies, Inc

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Source URL: www.fda.gov

Language: English
197Medicine / Center for Devices and Radiological Health / Abbreviated New Drug Application / Form FDA 483 / Title 21 CFR Part 11 / Food and Drug Administration / Pharmaceutical sciences / Health

Saving, Retrieving or Emailing your data can only be done with the full version of the Adobe Acrobat or the Adobe Approval and not with the free Adobe Reader. Retrieve Data Reset Form

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Source URL: www.mcswift.com

Language: English - Date: 2012-01-03 14:45:30
198Health / CRISIL / Market research / S&P / Food and Drug Administration / Form FDA 483 / Good manufacturing practice / Sun Pharmaceutical / Pharmaceutical industry / Pharmaceutical sciences / BSE Sensex / Pharmacology

June[removed]CRISIL Insight Indian pharma well-placed to weather spurt in FDA actions

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Source URL: www.crisil.com

Language: English - Date: 2014-07-03 07:11:55
199Validity / Biotechnology / Clinical research / Quality / Validation / Cell therapy / HTML element / Form FDA 483 / Fibroblast / Biology / Cell biology / Pharmaceutical industry

CMC REVIEW BLA[removed]Division of Cell and Gene Therapies, Office of Cellular, Tissue, and Gene Therapies Reviewed by:

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Source URL: www.fda.gov

Language: English
200Pharmaceutical sciences / Pharmacology / Clinical research / Pharmaceutical industry / Pharmaceuticals policy / Validation / Prescription Drug User Fee Act / Form FDA 483 / Clinical trial / Food and Drug Administration / Health / Medicine

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike

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Source URL: www.fda.gov

Language: English
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