FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

Review Period Set for Sankyo’s Benicar

07/31/2003

Federal Register Notice: FDA has determined the regulatory review period for Sankyo’s Benicar (olmesartan medocomil) is 2,52...

Panel to Discuss Palladone

07/31/2003

Federal Register Notice: FDA’s Anesthetic and Life Support Drugs Advisory Committee will meet 9/9-10 from 8 a.m. to 5 p.m. a...

Sponsor for 3 NADAs Changed to Schering

07/31/2003

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for three approved new ani...

Revised Blood Labeling/Storage Requirements Proposed

07/30/2003

Federal Register Proposed rule: FDA is proposing to revise the labeling and storage requirements for certain human blood and blood...

Class II Guidance on Breast Lesion Documentation Devices

07/28/2003

Federal Register Notice: FDA is classifying the breast lesion documentation system into Class II (special controls) and is making ...

Guidance on Good Review Management Principles

07/28/2003

Federal Register Notice: FDA is making available a draft guidance for reviewers and industry entitled Good Review Management Princ...

OMB OKs Info on Animal Drug Experience Reports

07/28/2003

Federal Register Notice: FDA’s collection of information entitled “Records and Reports Concerning Experience With Appr...

Info on Public Health Safety Alert Approved by OMB

07/28/2003

Federal Register Notice: FDA’s collection of information entitled “FDA Safety Alert/Public Health Advisory Readership ...

Meeting on Animal Feed Safety System

07/28/2003

Federal Register Notice: FDA will hold public meeting 9/23-24 to discuss the potential development of a comprehensive, risk-based ...

FDA OKs Bioniche ANADA for Horses

07/25/2003

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an abbreviated new animal drug app...