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Comments Sought on Lung Cancer Drug Info

07/08/2013

Info on Mammography Standards Sent to OMB

07/08/2013

Federal Register Notice: FDA’s proposed collection of information, “Mammography Quality Standards Act Requirements,&rd...

Guidance on Cellular and Gene Therapy Product Trials

07/08/2013

Federal Register Notice: FDA is making available a draft guidance entitled Guidance for Industry: Considerations for the Design of...

Comments Sought on Youth Tobacco Prevention

07/08/2013

Federal Register Notice: FDA seeks comments on Copy Testing of FDA’s General Market Youth Tobacco Prevention Campaigns. Copy...

Metadate ER Not Withdrawn for S&E

07/08/2013

Federal Register Notice: FDA has determined that Metadate ER (methylphenidate hydrochloride) extended-release tablet, 10 mg was no...

FDA Proposes More Harmonized Laser Products Standards

06/24/2013

Federal Register Proposed rule: FDA is proposing to amend the performance standard for laser products to achieve closer harmonizat...

Panel to Discuss Sanofi OTC Nasal Spray

06/24/2013

Federal Register Notice: FDA’s Nonprescription Drugs Advisory Committee will meet 7/31, from 8 a.m. to 5 p.m. at the DoubleT...

Panels to Discuss Harmful Tobacco Constituent Research

06/24/2013

Federal Register Notice: FDA’s Risk Communication and Tobacco Products Scientific Advisory Committees will meet 8/15, from 9...

FDA Releases Product-Specific BE Recommendations

06/20/2013

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

Guidance on ANDA Stability Testing

06/20/2013