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ICH Draft Guidance on Studies of Geriatric Populations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Federal Register Notice: FDA is making available a draft guidance entitled E7 Studies in Support of Special Populations: Geriatric...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

Comments Sought on IDE Reports/Records

10/23/2009

Federal Register Notice: FDA is seeking public comments on Investigational Device Exemptions Reports and Records —21 CFR Par...

Comments Sought on Third Party Device Inspectors

10/22/2009

Federal Register Notice: FDA seeks public comment on the publication of the criteria it intends to use to accredit third parties t...

Radiological Devices Panel to Meet

10/22/2009

Federal Register Notice: FDA’s Radiological Devices Panel of the Medical Devices Advisory Committee will meet 11/17-18, from...

Prescribing Info Labeling Guidance Out

10/19/2009

Federal Register Notice: FDA is making available a guidance for industry and review staff, Labeling for Human Prescription Drug an...