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Drug Master File
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11	Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Pharmaceuticals policy Food law Abbreviated New Drug Application New drug application Federal Food Drug and Cosmetic Act Generic drug Approved Drug Products with Therapeutic Equivalence Evaluations Center for Drug Evaluation and Research Drug Master File
12	Practical Guidance For the Paper Submission of Regulatory Information in Support of a Marketing Authorisation Application When Using an eCTD or a NeeS as the Source Submission. v2.0 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:51 Clinical research Clinical data management Electronic common technical document Pharmaceutical industry Pharmaceuticals policy Common Technical Document Marketing authorization Electronic submission Drug Master File
13	DOC Document Add to Reading List Source URL: www.ema.europa.eu Language: English - Date: 2016-07-20 07:22:57 Clinical research Pharmaceutical industry Clinical data management Drug safety Electronic common technical document Supplementary protection certificate European Medicines Agency Summary of Product Characteristics Pharmacovigilance Validation Drug Master File
14	Q&A on QP declaration Meeting with IPs on DCP_MRP Improvements 16. November 2016 Inger Heggebø The Norwegian Medicines Agency Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-11-27 10:53:15 Pharmaceutical industry Pharmaceuticals policy Drug Master File QP Qualified person
15	Uniform Certificate of Authority Application (UCAA) Corporate Amendments Application Checklist For Corporate Amendments Application Only The application checklist is intended to help guide the insurer (herein after refe Add to Reading List Source URL: www.naic.org Language: English - Date: 2016-08-04 09:25:23 Patent application SEC filings Drug Master File 111th United States Congress
16	April 2015 PUBLISHED VERSION (for information onlyApril 2015 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-07-03 10:50:42 Pharmaceutical industry Drug Master File Validation Marketing authorization
17	Additional ECEI Credentials Evaluation Report Request Form The fee for additional copies of evaluation reports is $50 per copy. To order additional copies, please complete this form and mail it with check or money order Add to Reading List Source URL: www.abet.org Language: English - Date: 2016-01-14 16:19:54 Economy Business Email Mail Cheque Drug Master File
18	Guide to the John Simon Guggenheim Memorial Foundation Online Application Add to Reading List Source URL: competition.gf.org Language: English - Date: 2015-07-08 09:50:11 Computing USB Form Rsum Email Business Economy Application for employment Drug Master File
19	CMDh QUESTIONS & ANSWERS ACTIVE SUBSTANCE MASTER FILE (ASMF) Doc. Ref.: CMDh, Rev.5 JanuaryIn order to enhance transparency between the applicant and the ASMF holder and to facilitate Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-02-19 09:47:04 Marketing authorization Marketing Authorization Application Pharmaceutical industry Pharmaceuticals policy Drug safety
20	CMDh QUESTIONS & ANSWERS ACTIVE SUBSTANCE MASTER FILE (ASMF) Doc. Ref.: CMDh, Rev.5 JanuaryIn order to enhance transparency between the applicant and the ASMF holder and to facilitate Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-02-19 09:47:04 Marketing authorization Marketing Authorization Application Pharmaceutical industry Pharmaceuticals policy Drug safety