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Comments Sought on Tobacco Quantitative Testing

07/17/2014

Federal Register Notice: FDA is seeking public comment on quantitative testing as used by the Food and Drug Administration Center ...

FDA Withdraws ANDAs Containing Acetaminophen

07/17/2014

Federal Register Notice: FDA is withdrawing approval of seven ANDAs for prescription drug products containing more than 325 mg of ...

Hearing on Interim Cardiovascular Outcome Results

07/15/2014

Federal Register Notice: FDA will hold a public hearing 8/11 that will provide a forum to discuss confidentiality of interim resul...

Guidance on Different Technological Characteristics in 510(k)s

07/15/2014

Federal Register Notice: FDA is making available a draft guidance document entitled Benefit-Risk Factors to Consider When Determin...

Guidance on Tobacco Substantial Equivalence Reports

07/15/2014

Federal Register Notice: FDA is making available a draft guidance entitled Substantial Equivalence Reports: Manufacturer Requests ...

Guidance on Informed Consent Information

07/15/2014

Federal Register Notice: FDA is making available a draft guidance entitled Informed Consent Information Sheet: Guidance for IRBs, ...

FDA Requires Tobacco Firms to Submit User Fee Info

07/10/2014

Federal Register Final rule: FDA is issuing a final rule that requires domestic tobacco product manufacturers and importers to sub...

FDA Updates Device Standards

07/09/2014

Federal Register Notice: FDA is publishing modifications to the list of standards the agency recognizes for use in premarket devic...

Comments Sought on Certification to Accompany Product Applications

07/09/2014

Federal Register Notice: FDA is seeking public comments on a proposed collection of information on Certification to Accompany Drug...

Guidance on Shedding Studies for Oncolytic Products

07/09/2014

Federal Register Notice: FDA is making available a draft document: Guidance for Industry: Design and Analysis of Shedding Studies ...