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
Location Changed for Nonprescription Drugs Panel Meeting
10/19/2012
Federal Register Notice: FDA is amending a notice of meeting of the 11/9 Nonprescription Drugs Advisory Committee to change the lo...
Guidance on eCopy Program for Device Submissions
10/17/2012
Oncologic Drugs Panel Meeting Canceled
10/17/2012
Panel to Discuss Influenza, Hepatitis B Vaccines
10/17/2012
Panel to Discuss Novartis NDA for Cushing’s Disease
10/17/2012
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 11/7, from 8 a.m. to 5 p.m. a...