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Errors Corrected in Bio Classification Final Rule

02/13/2004

Federal Register Final rule: FDA is correcting typographical errors in a final rule and final order from the 1/5 Federal Register ...

FDA OKs Ivy Labs sANADA for Feedlot Steers

02/13/2004

Federal Register Final rule: FDA is approving an Ivy Laboratories, Division of Ivy Animal Health supplemental abbreviated new anim...

FDA Submits Info on Mammography Facilities to OMB

02/09/2004

Federal Register Notice: FDA has submitted a proposed collection of information, “Mammography Facilities, Standards, and Lay...

Review Period Set For Extranael

02/09/2004

Federal Register Notice: FDA has determined that the regulatory review period for Baxter International, Inc.’s Extranael (ic...

Review Period Set for J & J’s Ortho-Evra

02/09/2004

Federal Register Notice: FDA has determined the regulatory review period for Johnson & Johnson’s Ortho-Evra is 2,001 days fo...

FDA Corrects Errors in Dura Mater/Allografts Notice

02/04/2004

Federal Register Interim final rule: FDA is correcting small errors in an interim final rule that published in the 1/27 Federal Re...

Comments Sought on Cell, Tissue Product Regs

01/29/2004

Federal Register Notice: FDA is seeking comment on the information collection requirements relating to FDA regulations for establi...

Review Period Set for Frova

01/29/2004

Federal Register Notice: FDA has determined the regulatory review period for Vernalis, Ltd.’s Frova is 2,201 days for the ex...

Remodulin’s Review Period is Set

01/29/2004

Federal Register Notice: FDA has determined the regulatory review period for United Therapeutics’ Remodulin is 4,026 days fo...

Review Period Set for Allergan’s Lumigan

01/28/2004

Federal Register Notice: FDA has determined the regulatory review period for Allergan’s Lumigan (bimatoprost) is 1,967 days ...