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Comments Sought on Safety Reporting, Electronic Submissions

11/18/2015

Federal Register Notice: FDA is seeking public comments on a proposed collection of information on the use of the FDA Electronic S...

Guidance on Biosimilar Sponsor Formal Meetings

11/18/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Formal Meetings Between the FDA and Biosimilar B...

FDA Posts Approved PMAs

11/18/2015

Federal Register Notice: FDA is publishing a list of PMAs that have been approved and is informing the public of the availability ...

Guidance on Labeling for Drugs Containing Acetaminophen

11/17/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Organ-Specific Warnings: Internal Analgesic, Ant...

Alexion Pharma Receives Voucher for Strensiq

11/17/2015

Federal Register Notice: FDA is issuing a priority review voucher to the sponsor of a rare pediatric disease product application, ...

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...