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Structured Product Labeling
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121	DOCUMENT INFORMATION PAGE Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2009-08-07 11:32:47 Biology Botulinum toxin Structured Product Labeling Allergan Botulism Spasmodic torticollis Federal Food Drug and Cosmetic Act Center for Drug Evaluation and Research Biologic License Application Medicine Food and Drug Administration Health
122	Guidance for Industry Providing Regulatory Submissions in Electronic Format — Prescription Drug Advertising and Promotional Labeling Draft Guidance Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical sciences Center for Biologics Evaluation and Research Influenza Biologic Center for Drug Evaluation and Research Electronic submission Structured Product Labeling Food and Drug Administration Medicine Health
123	Guidance for Industry Accelerated Approval Products — Submission of Promotional Materials DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical 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
124	Guidance for Industry Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments This guidance document is for immediate implementation. Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical research Pharmaceutical industry Center for Biologics Evaluation and Research Influenza Validation Biologic Structured Product Labeling Food and Drug Administration Medicine Pharmaceutical sciences
125	Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Add to Reading List Source URL: www.fda.gov Language: English Clinical research Food and Drug Administration Therapeutics United States Public Health Service New Drug Application Wyeth v. Levine Generic drug Structured Product Labeling Drug Price Competition and Patent Term Restoration Act Pharmaceutical sciences Pharmacology Pharmaceutical industry
126	[removed]P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N[removed]Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Biologics Evaluation and Research Federal Advisory Committee Act FDA Warning Letter Structured Product Labeling Food and Drug Administration Medicine Health
127	Lonnie Smith FDA Data Standards Council/OC/OIM Preparing GDUFA Self-ID SPL Files Using SPL Xforms Add to Reading List Source URL: www.fda.gov Language: English Structured Product Labeling Markup languages Form HTML Globally unique identifier Computing Web standards XForms
128	OxyContin (Oxycodone Hydrochloride Controlled-Release) Tablets. Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-04-16 16:29:28 Medical informatics Pharmaceutical sciences Pharmaceutical industry Structured Product Labeling Pharmaceuticals policy New Drug Application Federal Food Drug and Cosmetic Act Package insert Labeling theory Medicine Food and Drug Administration Health
129	Keyboard - golden key Success Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Structured Product Labeling Food and Drug Administration Abbreviated New Drug Application Data Universal Numbering System Generic drug Pharmaceutical industry Pharmaceutical sciences Pharmacology Medicine
130	Attachment B CDRH Draft Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov. Language: English Unique 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

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