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Panel to Discuss Shortwave Diathermy Device Reclassification

11/29/2012

Federal Register Notice: FDA’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will me...

Guidance on Preclinical Info for Cellular and Gene Therapy Products

11/29/2012

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Preclinical Assessment of Investigationa...

FDA Posts Planned CDRH Guidances

11/26/2012

Federal Register Notice: FDA is posting two lists on its Web site of CDRH guidance documents planned for FY 2013. Also, it has est...

Risk Communication Advisory Panel to Meet

11/26/2012

Federal Register Notice: FDA’s Risk Communication Advisory Committee will meet 2/12, from 8 a.m. to 3 p.m. at the FDA White ...

FDA Amends Dates on Device ID System Rule

11/19/2012

Federal Register Proposed rule: FDA is amending its 7/10 proposed rule (77 FR 40736) to establish a unique device identification (...

Comments Sought on Custom Device Exemption

11/19/2012

Federal Register Notice: FDA is seeking information on and examples of appropriate uses of the custom device exemption identified ...

FDA Publishes Notice of FDA User Fee System Records

11/14/2012

Federal Register Notice: FDA is publishing notice of a Privacy Act system of records entitled, “FDA User Fee System, HHS/FDA...

Info on Rx Drug User Fee Form Sent to OMB

10/22/2012

Federal Register Notice: FDA’s collection of information, “Prescription Drug User Fee Cover Sheet; Form FDA 3397,&rdqu...

Panel to Discuss NDA for Chronic Fatigue

10/22/2012

Location Changed for Endocrinologic Panel Meeting

10/19/2012