Structured Product Labeling

Results: 235



#Item
201Medicine / Health / Pharmacology / Therapeutics / United States Public Health Service / Regulatory requirement / Structured Product Labeling / Title 21 CFR Part 11 / Pharmaceutical sciences / Food and Drug Administration / Pharmaceuticals policy

Federal Register / Vol. 79, No. 9 / Tuesday, January 14, [removed]Notices include new food process filing forms and a new ‘‘smart form’’ system for electronic submission of these forms. The draft guidance, when fin

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Source URL: www.gpo.gov

Language: English - Date: 2014-01-14 07:55:08
202Clinical research / Government / Administrative law / Decision theory / Rulemaking / Federal Register / Request for Comments / Center for Tobacco Products / Structured Product Labeling / United States administrative law / Food and Drug Administration / Pharmaceutical sciences

This document is scheduled to be published in the Federal Register on[removed]and available online at http://federalregister.gov/a[removed], and on FDsys.gov[removed]P DEPARTMENT OF HEALTH AND HUMAN SERVICES

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Source URL: www.fda.gov

Language: English
203Documents / Guidance document / Publications / Pharmacology / Form FDA 483 / Structured Product Labeling / Food and Drug Administration / Pharmaceutical sciences / Clinical research

srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 76, No[removed]Friday, December 30, [removed]Notices last minute modifications that impact a previously announced advisory committee meeting cannot always be

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Source URL: www.gpo.gov

Language: English - Date: 2013-05-23 11:29:49
204XForms / Identifiers / Markup languages / Form / HTML / Globally unique identifier / Computing / Web standards / Structured Product Labeling

Preparing Electronic Drug Establishment Registration Submissions in SPL Format – Medicated Animal Feed Mills Version 1.0 Preface

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Source URL: www.fda.gov

Language: English
205Pharmaceutical industry / Pharmacology / Health / Generic drug / Public domain / Center for Drug Evaluation and Research / Authorized generics / Structured Product Labeling / Pharmaceutical sciences / Food and Drug Administration / Pharmaceuticals policy

Office of Generic Drugs Director’s Update – “LIFE WITH GDUFA”

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Source URL: www.fda.gov

Language: English
206Unique Device Identification / National Drug Code / Data Universal Numbering System / Medical device / Title 21 CFR Part 11 / Structured Product Labeling / Validation / Health Level 7 / Federal Food /  Drug /  and Cosmetic Act / Medicine / Food and Drug Administration / Health

Attachment B CDRH Draft Guidance Cover Sheet

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Source URL: www.fda.gov

Language: English
207Pharmaceuticals policy / Food and Drug Administration / Pharmacology / Pharmaceutical industry / Food law / Federal Food /  Drug /  and Cosmetic Act / Structured Product Labeling / Compounding / Good manufacturing practice / Health / Medicine / Pharmaceutical sciences

Guidance for Industry Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act DRAFT GUIDANCE

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Source URL: www.fda.gov

Language: English
208Pharmaceutical sciences / Pharmaceuticals policy / Pharmacology / Pharmaceutical industry / Food law / Structured Product Labeling / National Drug Code / Federal Food /  Drug /  and Cosmetic Act / Good manufacturing practice / Health / Food and Drug Administration / Medicine

Guidance for Industry Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act DRAFT GUIDANCE

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Source URL: www.fda.gov

Language: English
209Health / Pharmaceuticals policy / Pharmacology / Clinical pharmacology / United States Public Health Service / Center for Biologics Evaluation and Research / Regulatory requirement / Structured Product Labeling / Form FDA 483 / Food and Drug Administration / Medicine / Pharmaceutical sciences

2448 Federal Register / Vol. 79, No. 9 / Tuesday, January 14, [removed]Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Guidance title: Custom device exemption

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Source URL: www.gpo.gov

Language: English - Date: 2014-01-14 07:55:06
210Pharmacology / Food and Drug Administration / Pharmaceutical industry / Medical informatics / Piperazines / Package insert / Structured Product Labeling / Adverse effect / Norfloxacin / Medicine / Health / Pharmaceutical sciences

Script - An Introduction to the Improved FDA Prescription Drug Labeling Welcome and thank you for participating in the Food and Drug Administration, Center for Drug Evaluation and Research continuing education activity

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Source URL: www.fda.gov

Language: English
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