FDA Drug Manufacturing Inspections - REdI 2020

  Рет қаралды 9,130

U.S. Food and Drug Administration

U.S. Food and Drug Administration

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Пікірлер
FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017
17:35
U.S. Food and Drug Administration
Рет қаралды 2,4 М.
Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020
28:11
VIP ACCESS
00:47
Natan por Aí
Рет қаралды 30 МЛН
Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
1:22:14
U.S. Food and Drug Administration
Рет қаралды 16 М.
Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018
1:19:35
U.S. Food and Drug Administration
Рет қаралды 28 М.
Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017
1:20:20
Electronic Common Technical Document (eCTD) and Study Data (7of15) RedI - May 29-30, 2019
55:56
U.S. Food and Drug Administration
Рет қаралды 12 М.
Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018
44:31
Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017
46:00
U.S. Food and Drug Administration
Рет қаралды 21 М.
Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD
28:12
U.S. Food and Drug Administration
Рет қаралды 10 М.
Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018
33:18
Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017
54:28
U.S. Food and Drug Administration
Рет қаралды 16 М.