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Public Docket on LASIK Info Reopened

11/13/2009

Federal Register Notice: FDA is reopening until 11/15/10 a public docket to receive information and comments on post market experi...

Guidance on Registration for Tobacco Establishments

11/12/2009

Federal Register Notice: FDA is making available a guidance entitled Registration and Product Listing for Owners and Operators of ...

Regs Corrected on Genetically Engineered Animals

11/12/2009

Federal Register Notice: In Title 21 of the Code of Federal Regulations, Parts 500-599, revised as of 4/1, on page 359, the headin...

Comment Period Extended on CGMPs for Combo Products

11/10/2009

Federal Register Proposed rule: FDA is extending to 2/5/10, the comment period for the 9/23 proposed rule that requested comments ...

ICH Draft Guidance on Studies of Geriatric Populations

11/10/2009

Federal Register Notice: FDA is making available a draft guidance entitled E7 Studies in Support of Special Populations: Geriatric...

Revised Guidance on Structured Product Labeling

10/28/2009

Federal Register Notice: FDA is making available a draft revised guidance for industry and reviewers, SPL Standard for Content of ...

Science Advisory Board to Toxicological Center to Meet

10/28/2009

Federal Register Notice: FDA’s Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR) will me...

FDA Amends NADA Regs

10/23/2009

Federal Register Direct final rule/proposed rule: FDA is amending the regulations for new animal drug applications (NADAs) so that...

Comments Sought on Cattle-Derived Product Recordkeeping

10/23/2009

Federal Register Notice: FDA is seeking comments on the information collection requirements of FDA’s regulations that requir...

Comments Sought on Device User Fee Forms

10/23/2009

Federal Register Notice: FDA is seeking public comment on FDA Forms 3602 and 3602A which will allow domestic and foreign applicant...