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Drug Master File
Results: 255

#	Item
231	Guidance for Industry Initial Completeness Assessments for Type II API DMFs Under GDUFA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Health Pharmaceuticals policy Clinical research Drug Master File Food law New Drug Application Federal Food Drug and Cosmetic Act Generic drug Pharmaceutical industry Pharmaceutical sciences Medicine
232	Type II DMF Review Combined MaPPsa Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Packaging Drug Master File Industrial engineering Pharmacology Packaging and labeling Food contact materials Investigational New Drug Food and Drug Administration Health Medicine Technology
233	Guidance for Industry #169 - Drug Substance Add to Reading List Source URL: www.fda.gov Language: English Quality Medicine Technology Food and Drug Administration Pharmaceuticals policy Drug Master File Validation Federal Food Drug and Cosmetic Act Specification Pharmaceutical industry Pharmaceutical sciences Clinical research
234	GOOD MANUFACTURING PRACTICE COMPLIANCE STATUS Add to Reading List Source URL: www.fda.gov Language: English United States Department of Health and Human Services Health Medicine Pharmaceuticals policy Food safety Good manufacturing practice Title 21 of the Code of Federal Regulations Drug Master File Center for Drug Evaluation and Research Pharmaceutical industry Pharmaceutical sciences Food and Drug Administration
235	Guidance for Industry Comparability Protocols — Chemistry, Manufacturing, and Controls Information DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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 Health Clinical research Pharmacology Drug safety New Drug Application Center for Biologics Evaluation and Research Drug Master File Clinical trial Food and Drug Administration Medicine Pharmaceutical industry
236	MANUAL OF POLICIES AND PROCEDURES Add to Reading List Source URL: www.fda.gov Language: English Drug safety Medicine Health Drug Master File New Drug Application Investigational New Drug Pharmaceutical industry Food and Drug Administration Pharmaceutical sciences
237	Emergency IND Application Timeline Add to Reading List Source URL: www.fda.gov Language: English Drug safety Research Food and Drug Administration Clinical research Pharmaceutical industry Investigational New Drug Drug Master File Expanded access Institutional review board Pharmacology Medicine Pharmaceutical sciences
238	INSTRUCTIONS FOR FILLING OUT FORM FDA 356h – APPLICATION TO MARKET A NEW OR ABBREVIATED NEW DRUG OR BIOLOGIC FOR HUMAN USE (The field numbers below correspond to the numbered boxes on the Form FDA 356h) NOTE: Please su Add to Reading List Source URL: www.fda.gov Language: English Medicine Drug safety Health Clinical research New Drug Application Investigational New Drug Biologic License Application Drug Master File Food and Drug Administration Pharmaceutical industry Pharmaceutical sciences
239	ANDA Submissions – Prior Approval Supplements Under GDUFA Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Health Pharmacology Abbreviated New Drug Application Prescription Drug User Fee Act New Drug Application Generic drug Drug Master File Federal Food Drug and Cosmetic Act Pharmaceuticals policy Food and Drug Administration Pharmaceutical sciences
240	Question-based Review for Quality Assessment Of Generic Drugs Add to Reading List Source URL: www.fda.gov Language: English Clinical research Abbreviated New Drug Application Pharmacology Food and Drug Administration Email Anda Pharmaceutical sciences Pharmaceutical industry Drug Master File

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