Structured Product Labeling

Results: 235



#Item
181Medical informatics / Pharmaceutical sciences / Pharmacology / Pharmaceuticals policy / Food law / Structured Product Labeling / Abbreviated New Drug Application / Center for Drug Evaluation and Research / Alternative medicine / Medicine / Food and Drug Administration / Health

Guidance for Review Staff and Industry

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Source URL: www.fda.gov

Language: English
182Medical informatics / Structured Product Labeling / Pharmaceutical industry / Daily Med / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Package insert / Medical device / Index / Medicine / Food and Drug Administration / Health

Guidance for Industry - Indexing Structured Product Label

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Source URL: www.fda.gov

Language: English
183Pharmaceutical industry / Pharmaceutical sciences / Food law / Pharmaceuticals policy / Clinical research / Structured Product Labeling / Title 21 CFR Part 11 / New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Health

Guidance for Industry Providing Regulatory Submissions in Electronic Format Drug Establishment Registration and Drug Listing.

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Source URL: www.fda.gov

Language: English
184Research / Adverse Event Reporting System / Structured Product Labeling / Center for Biologics Evaluation and Research / New Drug Application / Postmarketing surveillance / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Health

Guidance for Industry Providing Submissions in Electronic Format — Postmarketing Safety Reports DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

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Source URL: www.fda.gov

Language: English
185Clinical research / Center for Biologics Evaluation and Research / Office of Regulatory Affairs / Center for Drug Evaluation and Research / Abbreviated New Drug Application / Center for Veterinary Medicine / Structured Product Labeling / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

Microsoft Word - 11121dft[removed]doc

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Source URL: www.fda.gov

Language: English
186Health / Pharmacology / Pharmaceutical industry / Therapeutics / United States Public Health Service / Medical device / Structured Product Labeling / Critical Path Institute / Medicine / Food and Drug Administration / Pharmaceutical sciences

Summaries of Transparency Task Force Listening Sessions with

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Source URL: www.fda.gov

Language: English
187Computing / Information / Structured Product Labeling / Globally unique identifier / Email / Data Universal Numbering System / Universally unique identifier / Form / Identifiers / Universal identifiers / Writing

Registration and listing examples

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Source URL: www.fda.gov

Language: English
188Pharmaceutical sciences / Structured Product Labeling / Title 21 CFR Part 11 / Title 21 of the Code of Federal Regulations / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / National Drug Code / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

From: Randy Levin, M.D. Associate Director for Medical Informatics Center for Drug Evaluation and Research FDA

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Source URL: www.fda.gov

Language: English
189Health / Adverse Event Reporting System / Center for Biologics Evaluation and Research / Electronic Common Technical Document / Center for Drug Evaluation and Research / Abbreviated New Drug Application / Title 21 CFR Part 11 / Structured Product Labeling / Food and Drug Administration / Medicine / Clinical research

Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
190Food and Drug Administration / Structured Product Labeling / Health Level 7 / Title 21 CFR Part 11 / Center for Biologics Evaluation and Research / Medicine / Health / Medical informatics

TO: Director, Division of Dockets Management, HFA 305 FROM: Michael Fauntleroy, Director CBER Electronic Submissions Program Subject: Docket 92S-0251 – Transmittal Pursuant to 21 CFR part 11.2(b)(2), and on behalf of t

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Source URL: www.fda.gov

Language: English
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