Drug Master File

Results: 255



#Item
191Research / Clinical research / Science / Food and Drug Administration / Dosage forms / Drug Master File / Pharmaceutical formulation / Excipient / Abbreviated New Drug Application / Pharmaceutical industry / Pharmacology / Pharmaceutical sciences

Microsoft Word - qoscecta_sgqecdec_ph_iii-eng.doc

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Source URL: www.hc-sc.gc.ca

Language: English - Date: 2013-07-12 14:26:07
192Research / Clinical research / Science / Food and Drug Administration / Drug Master File / Pharmaceutical formulation / Excipient / Dosage form / Abbreviated New Drug Application / Pharmacology / Pharmaceutical sciences / Pharmaceutical industry

Quality Overall Summary - Chemical Entities, Clinical Trial Application - Phase I

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Source URL: www.hc-sc.gc.ca

Language: English - Date: 2013-07-12 14:26:07
193Clinical research / Research / Science / Food and Drug Administration / Dosage forms / Drug Master File / Pharmaceutical formulation / Excipient / Abbreviated New Drug Application / Pharmacology / Pharmaceutical industry / Pharmaceutical sciences

Microsoft Word - qoscecta_sgqecdec_ph_ii-eng.doc

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Source URL: www.hc-sc.gc.ca

Language: English - Date: 2013-07-12 14:26:07
194Membrane biology / Pharmaceutical industry / Clinical research / Drug safety / Food and Drug Administration / Liposome / Lipid bilayer / Drug Master File / Bioequivalence / Pharmacology / Pharmaceutical sciences / Medicine

Guidance for Industry Liposome Drug Products Chemistry, Manufacturing, and Controls; Human

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Source URL: www.fda.gov

Language: English
195Pharmaceutical 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

Guidance for Industry Comparability Protocols — Chemistry, Manufacturing, and Controls Information DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

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Source URL: www.fda.gov

Language: English
196Medicine / Pharmaceutics / Clinical research / Drug Master File / Pharmacology / Natural Health Products / Clinical trial / Health Products and Food Branch / Guidance document / Pharmaceutical industry / Health Canada / Health

Microsoft Word - draft_ebauche_dmf_fmm_guide_ld-eng.doc

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Source URL: www.hc-sc.gc.ca

Language: English - Date: 2013-07-12 14:25:40
197Pharmaceutical sciences / Health / Pharmaceuticals policy / Drug safety / Drug Master File / Pharmacology / New Drug Application / Investigational New Drug / Regulatory requirement / Food and Drug Administration / Pharmaceutical industry / Medicine

Guidance for Industry Drug Master Files for Bulk Antibiotic Drug Substances U.S. Department of Health and Human Services Food and Drug Administration

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Source URL: www.fda.gov

Language: English
198Health / Pharmaceutical sciences / Validation / Drug Master File / Office of Regulatory Affairs / Medical device / Investigational New Drug / ClinicalTrials.gov / Unique Device Identification / Medicine / Food and Drug Administration / Pharmaceutical industry

9468 Federal Register / Vol. 79, No[removed]Wednesday, February 19, [removed]Notices www.regulations.gov. Submit written comments to the Division of Dockets

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Source URL: www.gpo.gov

Language: English - Date: 2014-02-19 01:00:16
199Pharmaceutical sciences / Health / Pharmaceutical industry / Food law / Clinical research / Drug Master File / New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Pharmaceuticals policy

Federal Register / Vol. 76, No[removed]Monday, March 14, [removed]Notices Acculturation: A Systematic Review of Public Health Studies With Hispanic Population in the United States,’’ Social Science & Medicine, 69: 983–

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Source URL: www.gpo.gov

Language: English - Date: 2013-05-23 13:05:06
200Pharmaceuticals policy / Medicine / Pharmacology / Clinical research / Food law / Drug Master File / Abbreviated New Drug Application / New Drug Application / Generic drug / Pharmaceutical industry / Pharmaceutical sciences / Food and Drug Administration

PDF Document

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Source URL: www.fda.gov

Language: English
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