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Drug Master File
Results: 255

#	Item
221	Guidance for Industry Generic Drug User Fee Amendments of 2012: Questions and Answers DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacology Medicine Drug Master File Prescription Drug User Fee Act Abbreviated New Drug Application New Drug Application Generic drug Federal Food Drug and Cosmetic Act Pharmaceutical sciences Food and Drug Administration Pharmaceuticals policy
222	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
223	Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Pharmaceuticals policy Food safety Food and Drug Administration Clinical research Drug Master File New Drug Application Generic drug Shelf life Pharmaceutical industry Pharmaceutical sciences Pharmacology
224	Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics CHEMISTRY, MANUFACTURING, AND CONTROLS DOCUMENTATION U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceuticals policy Clinical research Pharmacology Drug Master File Packaging and labeling Center for Biologics Evaluation and Research Biologic Pharmaceutical industry Food and Drug Administration Pharmaceutical sciences
225	Guidance for Industry M4: The CTD — Quality Questions and Answers/ Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacology Clinical Data Management Pharmaceuticals policy Validation Drug Master File International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Common Technical Document HTML element Clinical research Research Pharmaceutical sciences
226	Guidance for Industry Submitting Marketing Applications According to the ICH-CTD Format — Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Clinical Data Management Drug safety Common Technical Document New Drug Application International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Drug Master File Center for Biologics Evaluation and Research Clinical research Research Medicine
227	PET Drug Applications — Content and Format for NDAs and ANDAs Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Clinical research Research Drug safety New Drug Application Drug Master File Approved drug Positron emission tomography Approved Drug Products with Therapeutic Equivalence Evaluations Medicine Pharmaceutical industry Food and Drug Administration
228	U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Medicine Drug safety Health Clinical research Pharmaceuticals policy Drug Master File New Drug Application Investigational New Drug Generic drug Pharmaceutical industry Food and Drug Administration Pharmaceutical sciences
229	Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Medicine Food and Drug Administration Dosage forms Clinical research Excipient Pre-clinical development Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Drug Master File Pharmaceutical sciences Pharmacology Pharmaceutical industry
230	Guidance for Industry Changes to an Approved NDA or ANDA Questions and Answers U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceuticals policy Clinical research Food law Drug Master File New Drug Application Good manufacturing practice Center for Drug Evaluation and Research Pharmaceutical industry Food and Drug Administration Pharmaceutical sciences

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