Drug Master File

Results: 255



#Item
131Pharmacology / Health / Drug safety / Pharmacy / European Medicines Agency / Qualified Person for Pharmacovigilance / Drug Master File / Marketing authorization / Test data exclusivity / Pharmaceutical sciences / Pharmaceutical industry / Pharmaceuticals policy

DOC Document

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Source URL: www.pvd.gov.lv

Language: English - Date: 2013-08-29 03:48:56
132Medicine / Health / Drug safety / Pharmacology / Clinical research / Investigational New Drug / Drug Master File / Quality by Design / New Drug Application / Food and Drug Administration / Pharmaceutical industry / Pharmaceutical sciences

PIC BY GORDON WILTSIE / NATIONAL GEOGRAPHIC STOCK / CATERS NEWS - Hanging precariously in TENTS off a jaw-dropping 4,000ft vertical cliff face wouldnt be most peoples idea of the perfect camping trip.But for these darede

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Source URL: www.fda.gov

Language: English
133Food and Drug Administration / Pharmacology / Health / Clinical research / Drug safety / Panitumumab / Investigational New Drug / Drug Master File / Monoclonal antibodies / Pharmaceutical industry / Medicine / Pharmaceutical sciences

[89Zr]-PANITUMUMAB; [89Zr]-PAN FREQUENTLY ASKED QUESTIONS What is the status of [89Zr]-panitumumab at the Cancer Imaging Program? What is the Regulatory Status of [89Zr]-panitumumab? How can I use [89Zr]-panitumumab in m

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Source URL: imaging.cancer.gov

Language: English - Date: 2013-08-28 14:13:00
134Pharmacology / Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme / Site Master File / Medicines and Healthcare products Regulatory Agency / Food and Drug Administration / Pharmaceutical industry / Pharmaceutical sciences / Pharmaceutics

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME 12 June 2003 PRESS RELEASE PIC/S COMMITTEE MEETING

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Source URL: www.picscheme.org

Language: English - Date: 2012-06-04 15:31:16
135Pharmacology / Pharmaceuticals policy / Clinical research / Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme / Medicines and Healthcare products Regulatory Agency / Site Master File / Food and Drug Administration / Pharmaceutical industry / Pharmaceutical sciences / Pharmaceutics

ANNUAL REPORT[removed]Pharmaceutical Inspection Co -operation Scheme The Pharmaceutical Inspection Co-operation Scheme (PIC Scheme), which entered into force in November 1995, is an informal and flexible arrangement betwee

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Source URL: www.picscheme.org

Language: English - Date: 2012-06-04 15:31:25
136Food and Drug Administration / Research / Medicine / Drug safety / Clinical research / Investigational New Drug / Drug Master File / New Drug Application / Drug development / Pharmacology / Pharmaceutical sciences / Pharmaceutical industry

[18F]FLUOROMISONIDAZOLE, [18F]FMISO FREQUENTLY ASKED QUESTIONS What is the status of FMISO at the Cancer Imaging Program? What is the Regulatory Status of FMISO? How can I use FMISO in my clinical trial? Can I make my ow

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Source URL: imaging.cancer.gov

Language: English - Date: 2013-07-08 15:22:39
137Pharmacology / Food and Drug Administration / Fluorides / Metal halides / New Drug Application / Drug Master File / Sodium fluoride / Drug development / Pharmaceutical industry / Chemistry / Pharmaceutical sciences

[18F] NaF FREQUENTLY ASKED QUESTIONS What is the status of sodium fluoride at the Cancer Imaging Program? What is the regulatory status of sodium fluoride? How can I use sodium fluoride in my clinical trial? Can I make m

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Source URL: imaging.cancer.gov

Language: English - Date: 2013-07-08 15:22:41
138Pharmacology / Pharmaceuticals policy / Health / Center for Drug Evaluation and Research / Generic drug / New Drug Application / Heather Bresch / Drug Master File / Mylan / Pharmaceutical sciences / Pharmaceutical industry / Food and Drug Administration

GDUF Negotiations Meeting[removed]PUBLIC Minutes

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Source URL: www.fda.gov

Language: English
139Pharmacology / Research / Medicine / Drug safety / Clinical research / Investigational New Drug / Drug Master File / New Drug Application / Drug development / Pharmaceutical industry / Pharmaceutical sciences / Food and Drug Administration

[18F]FLUOROESTRADIOL, [18F]FES FREQUENTLY ASKED QUESTIONS What is the status of FES at the Cancer Imaging Program? What is the Regulatory Status of FES? How can I use FES in my clinical trial? Can I make my own FES?

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Source URL: imaging.cancer.gov

Language: English - Date: 2013-07-08 15:22:43
140Clinical research / Pharmacokinetics / Pharmaceuticals policy / Drug Master File / Bioequivalence / Validation / Abbreviated New Drug Application / Good manufacturing practice / Food and Drug Administration / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

J:licationsrmaceutical Sciences Q&Aking copyqa_sp_qr_e.wpd

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

Language: English - Date: 2013-07-12 14:26:03
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