NDLI: Impact of Expanded Access on FDA Regulatory Action and Product Labeling

Content Provider	Scilit
Author	Jarow, Jonathan P. Moscicki, Richard
Copyright Year	2017
Related Links	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6075680/pdf
Ending Page	789
Page Count	3
Starting Page	787
ISSN	21684790
e-ISSN	21684804
DOI	10.1177/2168479017707800
Journal	Therapeutic Innovation & Regulatory Science
Issue Number	6
Volume Number	51
Language	English
Publisher	SAGE Publications
Publisher Date	2017-11-01
Access Restriction	Open
Subject Keyword	Journal: Therapeutic Innovation & Regulatory Science Medical Informatics Expanded Access New Drug Application Drug Development Compassionate Use
Content Type	Text
Resource Type	Article
Subject	Public Health, Environmental and Occupational Health Pharmacology, Toxicology and Pharmaceutics Pharmacology (medical)

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Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Impact of Expanded Access on FDA Regulatory Action and Product Labeling