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FDA Plans Conference on Drug-Induced Liver Injuries

12/19/2014

Federal Register Notice: FDA will hold a public conference 3/18-19/15 entitled “Serious Drug-Induced Liver Injury (DILI): Th...

Info on Form FDA 3674 Sent to OMB

12/19/2014

Federal Register Notice: FDA’s proposed collection of information, “Certification To Accompany Drug, Biological Produc...

Public Meeting on Breast Cancer Drug Development

12/19/2014

Federal Register Notice of public meeting: FDA will hold a public meeting 4/2 on patient-focused drug development for breast cance...

FDA Proposes Electronic Prescribing Info on Drugs/Biologics

12/18/2014

Federal Register Proposed rule: FDA is proposing to amend its prescription drug and biological product labeling regulations to req...

FDA Sends Collection of Info on Fast-Track Drugs to OMB

12/18/2014

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry: Fast Track Drug Development...

Info on Orphan Products Sent to OMB

12/18/2014

Federal Register Notice: FDA’s proposed collection, “Draft Guidance for Industry, Researchers, Patient Groups, and Foo...

Guidance on Study Data E-Submissions

12/18/2014

Federal Register Notice: FDA is making available a guidance for industry: Providing Regulatory Submissions in Electronic Format &m...

Info on Biologic Cooperative Manufacturing Sent to OMB

12/18/2014

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry: Cooperative Manufacturing A...

Guidance on E-Format Submissions Under FDCA 745A(a)

12/18/2014

Federal Register Notice: FDA is making available a guidance: Providing Regulatory Submissions in Electronic Format — Submiss...

FDA Corrects Notice on Commissioning of State/Local Officials

12/16/2014

Federal Register Notice: FDA is correcting a 12/8 Federal Register notice that misstated the effective date of the new system of r...