Drug user

Results: 1369



#Item
421Pharmaceutical industry / Management / Pharmaceuticals policy / Quality by Design / Pharmacology / Food and Drug Administration / Prescription Drug User Fee Act / Manufacturing / Process analytical technology / Quality / Business / Pharmaceutical sciences

Consumer Healthcare Products Association

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Source URL: www.fda.gov

Language: English
422Medical informatics / Competitions / Digital media / Research / Electronic Common Technical Document / Science / Electronic submission / Graphical user interface / Portable Document Format / Computing / Clinical Data Management / Clinical research

Ensuring a Successful Submission Connie Robinson-Kuiperi, RAC, PMP Office of Business Process Support Center for Drug Evaluation and Research November 5, 2008

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Source URL: www.fda.gov

Language: English
423Health / Pharmaceutical sciences / Pharmacology / Drug safety / Drugs / Prescription Drug User Fee Act / New Drug Application / Over-the-counter drug / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Pharmaceuticals policy

Microsoft Word - 8945fnl.doc

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Source URL: www.fda.gov

Language: English
424Clinical research / Health / Clinical pharmacology / Therapeutics / United States Public Health Service / MedWatch / Expanded access / Patient safety organization / Prescription Drug User Fee Act / Food and Drug Administration / Pharmacology / Pharmaceutical sciences

Staff Manual Guide[removed]

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Source URL: www.fda.gov

Language: English
425Pharmaceutical sciences / Center for Devices and Radiological Health / Medical device / Prescription Drug User Fee Act / Premarket approval / Center for Biologics Evaluation and Research / Federal Food /  Drug /  and Cosmetic Act / New Drug Application / Good manufacturing practice / Food and Drug Administration / Medicine / Health

F-D-C REPORTS — FOUNDED 1939 $490 A YEAR “The Silver Sheet” 

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Source URL: www.fda.gov

Language: English
426Pharmaceutical sciences / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Biologic / FDA Fast Track Development Program / Federal Food /  Drug /  and Cosmetic Act / Prescription Drug User Fee Act / Structured Product Labeling / Food and Drug Administration / Medicine / Health

Guidance for Industry Accelerated Approval Products — Submission of Promotional Materials DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

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Source URL: www.fda.gov

Language: English
427Pharmaceutical sciences / Prescription Drug User Fee Act / New Drug Application / Investigational New Drug / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Clinical research / Food and Drug Administration / Medicine / Health

Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds U.S. Department of Health and Human Services Food and Drug Administration

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Source URL: www.fda.gov

Language: English
428Prescription Drug User Fee Act / Pharmacology / Health / Drug safety / Patent law / New Drug Application / Priority right / Food and Drug Administration / Pharmaceutical sciences / Pharmaceuticals policy

st 21 Century Review Judit Milstein

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Source URL: www.fda.gov

Language: English
429Medicine / Health / Food law / Pharmaceutical industry / Prescription Drug User Fee Act / Federal Food /  Drug /  and Cosmetic Act / New chemical entity / New Drug Application / FDA Special Protocol Assessment / Food and Drug Administration / Pharmaceutical sciences / Pharmaceuticals policy

Draft — Not for Implementation Attachment IV Sample Formats — User Fee Form FDA 3397 for

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Source URL: www.fda.gov

Language: English
430Medicine / Pharmaceutical industry / Health / Pharmacology / Drug safety / Drug Master File / New Drug Application / Prescription Drug User Fee Act / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Pharmaceutical sciences / Pharmaceuticals policy

Guidance for Industry and Reviewers Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
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