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Comments Sought on Drug Hypertension Labeling

04/18/2013

Federal Register Notice: FDA is seeking comments on the information collection associated with the guidance Hypertension Indicatio...

Info on Restricting Tobacco Sales Sent to OMB

04/08/2013

Federal Register Notice: FDA’s proposed collection of information, “Regulations Restricting the Sale and Distribution ...

FDA Releases Product-Specific BE Guidance

04/08/2013

Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommend...

Tobacco Panel to Meet

04/08/2013

Federal Register Notice: FDA’s Tobacco Products Scientific Advisory Committee will meet 4/30, from 8:30 a.m. to 5:30 p.m. at...

CBER Invites Participants for eSubmitter Pilot

04/08/2013

Federal Register Notice: CBER is inviting sponsors of IND applications to participate in a pilot evaluation program for CBER&rsquo...

Guidance on Postmarket Periodic Safety Reports

04/08/2013

Federal Register Notice: FDA is making available a draft guidance, Providing Postmarket Periodic Safety Reports in the ICH E2C(R2)...

CDRH Plans Health of Women Workshop

04/08/2013

Federal Register Notice: FDA will hold a public workshop 6/24-25, “The CDRH Health of Women Program: Educate, Enable, Enlist...

FDA Proposes PMA or PDP for 3 Devices

04/04/2013

FDA/PDA Conference on Quality, Compliance in Product Life Cycle

04/04/2013

Federal Register Notice: FDA and the Parenteral Drug Association will co-sponsor a public conference 9/16-18: “Driving Quali...

FDA Amends Testosterone Panel Notice

04/04/2013

Federal Register Notice: FDA is amending the 3/14 notice of the 4/18 joint meeting of the Advisory Committee for Reproductive Heal...