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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

FDA Publishes Approved PMA List

06/12/2013

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

Comments Sought on Orphan Drug Procedures Info

06/12/2013

Federal Register Notice: FDA seeks comment on the proposed collection of information on the procedures by which sponsors of orphan...

Comments Sought on Electronic Product Requirements

06/12/2013

FDA Amends Orphan Drug Regs

06/12/2013

Federal Register Final rule: FDA is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Or...

FDA Proposes Serious Pathogen List

06/12/2013