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OMB OKs Info on In Vivo Radiopharmaceuticals

11/22/2005

Federal Register Notice: FDA’s collection of information entitled “Regulations For In Vivo Radiopharmaceuticals Used For Diagnosis...

New Numbers Assigned to INDs

11/17/2005

Federal Register Notice: CDER will assign new numbers to a group of investigational new drug applications because the 2003 consoli...

Info on Triptans for Migraines Sent to OMB

11/02/2005

Federal Register Notice: FDA has submitted a proposed collection of information entitled, “Study to Measure the Compliance of Pres...

FDA OKs Ivy Labs ANADA for Heifer Feed

11/02/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Ivy Laboratories ANADA for use ...

Guidance on Potassium Chlordide ANDAs

10/26/2005

Federal Register Notice: FDA is making available a guidance for industry entitled “Potassium Chloride Modified-Release Tablets and...

Panel to Discuss Influenza, Pneumococcal Vaccines

10/26/2005

Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 11/16, from 8:30 a.m. to 5:15...

Gene Mutation Detection Systems Are in Class 2

10/26/2005

Federal Register Final rule: FDA is classifying the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detec...

Science Board to FDA to Meet

10/21/2005

Federal Notice: The Science Board to FDA will meet 11/4-5, from 8:30 a.m. to 4 p.m. at the Washington Room, Holiday Inn Bethesda, ...

Guidance on Nonclinical Evaluation of QT

10/20/2005

Federal Register Notice: FDA is making available a guidance entitled S7B Nonclinical Evaluation of the Potential for Delayed Ventr...

Guidance on Proarrhythmic Potential for Non-Antiarrhythmics

10/20/2005

Federal Register Notice: FDA is making available a guidance entitled E14 Clinical Evaluation of QT/QTc Interval Prolongation and P...