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Drug Master File
Results: 255

#	Item
21	Fact sheet 28 March, 2014 China Hong Kong Add to Reading List Source URL: www.jpma.or.jp Language: English - Date: 2014-06-26 21:25:06 Research Pharmacology Drug safety Food and Drug Administration Electronic Common Technical Document New Drug Application Drug Master File Quality by Design FDA Fast Track Development Program Pharmaceutical sciences Pharmaceutical industry Clinical research
22	9 April 2013 EMARev 1* Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file (Rev 1) Add to Reading List Source URL: www.ema.europa.eu Language: English - Date: 2013-07-21 06:33:00 Health Pharmaceuticals policy Pharmacy Clinical research Qualified Person Responsible For Pharmacovigilance Qualified Person for Pharmacovigilance Pharmacovigilance European Medicines Agency EudraVigilance Pharmaceutical sciences Pharmacology Drug safety
23	Microsoft Word - PAR_1242_DC_22 mar 2010.doc Add to Reading List Source URL: db.cbg-meb.nl Language: English - Date: 2012-10-07 10:18:08 Pharmaceutical industry Lactams Bristol-Myers Squibb Irbesartan Angiotensin II receptor antagonist Bioequivalence Generic drug Drug Master File Aspirin Chemistry Organic chemistry Pharmacology
24	Task B Proposal Document APAC RA-EWG Task B Convergence of NDA Requirements Add to Reading List Source URL: www.jpma.or.jp Language: English - Date: 2014-06-26 21:25:06 Clinical research Food and Drug Administration Drug discovery Clinical trial FDA Fast Track Development Program Drug Master File Regulatory requirement Drug development Pharmaceutical sciences Pharmacology Pharmaceutical industry
25	Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Research Medicine Clinical research Pharmacology Drug safety Validation Center for Biologics Evaluation and Research Drug Master File Biologic Food and Drug Administration Pharmaceutical industry Pharmaceutical sciences
26	DRAFT 5 APPENDIX 13: DRUG MASTER FILES AND CERTIFICATES OF SUITABILITY 1. GENERAL OVERVIEW 1.1. Add to Reading List Source URL: www.sirim.my Language: English - Date: 2014-09-11 02:54:34 Technology Drug Master File Pharmaceuticals policy Validity Business Evaluation Validation Specification Application programming interface Pharmaceutical industry Quality Technical communication
27	MARCH 19TH, 2014 DMF 101 Inside This Issue 1 Add to Reading List Source URL: www.fda.gov Language: English Medicine Drug safety Pharmaceutics Drug Master File Pharmaceuticals policy New Drug Application Investigational New Drug Generic drug Pharmaceutical industry Pharmaceutical sciences Food and Drug Administration
28	Contact: Christine Palus Telephone: ([removed]Email: [removed] FOR IMMEDIATE RELEASE Add to Reading List Source URL: www.lyophilization.com Language: English - Date: 2014-08-01 11:59:59 Pharmacology Drug Master File New Drug Application Food and Drug Administration Good manufacturing practice Investigational New Drug Medicines and Healthcare products Regulatory Agency Site Master File Medical device Pharmaceutical industry Pharmaceutical sciences Medicine
29	Inhalation Drug Products Packaged in Semipermeable Container Closure Systems Add to Reading List Source URL: www.fda.gov Language: English Polyolefins Dielectrics Business Chemistry Containers Packaging and labeling Low-density polyethylene Closure Drug Master File Technology Pharmaceutical industry Packaging materials
30	Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Research Medicine Clinical research Pharmacology Drug safety Validation Center for Biologics Evaluation and Research Drug Master File Biologic Food and Drug Administration Pharmaceutical industry Pharmaceutical sciences