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Draft Guidance on Pediatric Devices

07/24/2003

Federal Register Notice: FDA is making available a draft guidance entitled Premarket Assessment of Pediatric Medical Devices. This...

Correction on Reprocessed Device Notice

07/23/2003

Federal Register Notice: FDA is correcting a docket number from a notice that appeared in the 7/8 Federal Register announcing the ...

FDA Submits Info on Electronic Records to OMB

07/23/2003

Federal Register Notice: FDA’s proposed collection of information “Electronic Records; Electronic Signatures — 2...

Info on Clinical Holds Submitted to OMB

07/23/2003

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry — Submitting and Revie...

Error Corrected on Reprocessed Devices Info

07/23/2003

Federal Register Notice: FDA is correcting a notice from the 7/8 Federal Register announcing that a proposed collection of informa...

Panel to Vote on Embolization PMA

07/23/2003

Federal Register Notice: FDA’s Neurological Devices Panel of the Medical Devices Advisory Committee will meet 8/5, from 10 a...

Location Corrected on Advisory Meeting

07/23/2003

Federal Register Notice: FDA is announcing an amendment to the location portion of the notice of the 9/18 meeting of the Drug Safe...

Panel to Discuss Glaxo COPD Drug

07/23/2003

Federal Register Notice: FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet 9/5, from 8 a.m. to 5:30 p.m. at the Hol...

Comments Sought on Bio Labeling Requirements

07/22/2003

Federal Register Notice: FDA is seeking public comment on the information collection requirements related to certain biologics lab...

Merial Adds New Parasites to Ivermectin Label

07/22/2003

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