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Comments Sought on ADE Reports for Unapproved OTC Drugs

01/23/2015

Federal Register Notice: FDA is seeking public comment on the FDA guidance for industry on Postmarketing Adverse Event Reporting f...

Science Board Nominations Sought

01/23/2015

Federal Register Notice: FDA is requesting nominations for members to serve on the Science Board to FDA. Nominations received on o...

Comments Sought on Drug/Biologic Labeling Requirements

01/21/2015

Federal Register Notice: FDA is seeking public comments on the information collection provisions of FDA’s requirements on co...

FDA Releases Study Data Conformance Guide

01/12/2015

Federal Register Notice: FDA is making available a Study Data Technical Conformance Guide, Version 2.0, and an update to the Data ...

Comments Sought on Burden of Animal Drugs BE Guidance

01/12/2015

Federal Register Notice: FDA seeks comments on the current burden hours on regulated industry of complying with the guidance, Waiv...

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...