Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies

  Рет қаралды 8,536

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Күн бұрын

Пікірлер
FDA Drug Topics: Reporting and Public Viewing of Individual Case Safety Reports (ICSRs) May 24, 2022
43:54
FDA Drug Topics: Reporting and Public Viewing of Individual Case Safety Reports (ICSRs) May 24, 2022
U.S. Food and Drug Administration
Рет қаралды 2,3 М.
FDA Clinical Investigator Training Course (CITC) 2023, Day 1 - Part 3
1:30:51
FDA Clinical Investigator Training Course (CITC) 2023, Day 1 - Part 3
U.S. Food and Drug Administration
Рет қаралды 2,4 М.
😜 #aminkavitaminka #aminokka #аминкавитаминка
00:14
😜 #aminkavitaminka #aminokka #аминкавитаминка
Аминка Витаминка
Рет қаралды 2,3 МЛН
Kluster Duo #настольныеигры #boardgames #игры #games #настолки #настольные_игры
00:47
Kluster Duo #настольныеигры #boardgames #игры #games #настолки #настольные_игры
Двое играют | Наташа и Вова
Рет қаралды 13 МЛН
ЛУЧШИЙ ФОКУС + секрет! #shorts
00:12
ЛУЧШИЙ ФОКУС + секрет! #shorts
Роман Magic
Рет қаралды 11 МЛН
Seja Gentil com os Pequenos Animais 😿
00:20
Seja Gentil com os Pequenos Animais 😿
Los Wagners
Рет қаралды 69 МЛН
FDA Clinical Investigator Training Course (CITC) 2023, Day 1 - Part 1
1:56:22
FDA Clinical Investigator Training Course (CITC) 2023, Day 1 - Part 1
U.S. Food and Drug Administration
Рет қаралды 7 М.
Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018
33:18
Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018
U.S. Food and Drug Administration
Рет қаралды 12 М.
Bioequivalence Regulations and Product-Specific Guidances
19:15
Bioequivalence Regulations and Product-Specific Guidances
U.S. Food and Drug Administration
Рет қаралды 3 М.
Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020
27:10
Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020
U.S. Food and Drug Administration
Рет қаралды 8 М.
Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)- Nov. 1, 2019
55:59
Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)- Nov. 1, 2019
U.S. Food and Drug Administration
Рет қаралды 10 М.
Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance 2020
56:41
Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance 2020
U.S. Food and Drug Administration
Рет қаралды 5 М.
Postmarketing Adverse Drug Experience (PADE) Inspections - (1of3) Jun. 19, 2018
1:03:54
Postmarketing Adverse Drug Experience (PADE) Inspections - (1of3) Jun. 19, 2018
U.S. Food and Drug Administration
Рет қаралды 2,7 М.
Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 1 - Part 4
1:01:38
Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 1 - Part 4
U.S. Food and Drug Administration
Рет қаралды 467
Global IDMP Implementation - Getting Closer to the Goal
1:25:26
Global IDMP Implementation - Getting Closer to the Goal
U.S. Food and Drug Administration
Рет қаралды 392
Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 1 - Part 2
1:12:08
Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 1 - Part 2
U.S. Food and Drug Administration
Рет қаралды 574
😜 #aminkavitaminka #aminokka #аминкавитаминка
00:14
😜 #aminkavitaminka #aminokka #аминкавитаминка
Аминка Витаминка
Рет қаралды 2,3 МЛН