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OMB OKs Info on Electronic Labeling Submissions

12/16/2003

Federal Register Notice: FDA’s collection of information entitled “Requirements for Submission of Labeling for Human P...

OMB OKs Info on Clinical Holds

12/16/2003

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry: Submitting and Reviewing Com...

Comments Sought on 510(k) Requirements

12/16/2003

Federal Register Notice: FDA is seeking public comment on requirements for premarket notification (510(k)) submissions Comments sh...

Guidance on Blood/Components Labeling

12/10/2003

Federal Register Notice: FDA is making available a document entitled Guidance for Industry: An Acceptable Circular of Information ...

FDA OKs Phoenix Scientific sANADA for Honeybees/Swine

12/10/2003

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental abbreviated new ani...

FDA Approves Boehringer NADA for Canine Osteoarthritis

12/10/2003

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a new animal drug application (NAD...

Comments Sought on Collecting Postmarket Race Data

12/08/2003

Federal Register Notice: FDA is requesting comment on the advantages and disadvantages of systematically collecting race and ethni...

Guidance on Bundling Device Submissions

11/26/2003

Federal Register Notice: FDA is making available a guidance entitled Bundling Multiple Devices or Multiple Indications in a Single...

Guidance on Expedited Device Review

11/26/2003

Federal Register Notice: FDA is making available the guidance entitled Expedited Review of Premarket Submissions for Devices. This...

FDA Sets Review Period for Abilify

11/26/2003

Federal Register Notice: FDA has determined the regulatory review period for Otsuka Pharmaceutical’s Abilify (aripiprazole) ...