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GEM 21S Review Period Set

06/01/2007

Federal Register Notice: FDA has determined the regulatory review period for GEM 21S Growth Factor Enhanced Matrix is 1,361 days f...

Review Period Set for Myozyme

05/25/2007

Federal Register Notice: FDA has determined the regulatory review period for Genzyme Corp.’s Myozyme is 1,225 days for exten...

Review Period Set for Prezista

05/25/2007

Federal Register Notice: FDA has determined the regulatory review period for Ortho Biotech’s Prezista is 1,253 days for exte...

Comments Extended on Alternative Medicine Guidance

05/25/2007

Federal Register Notice: FDA will consider comments submitted through 5/29, for a draft guidance for industry entitled Complementa...

Sprycel Review Period Determined

05/25/2007

Federal Register Notice: FDA has determined the regulatory review period for Bristol-Myers Squibb’s Sprycel, NDAs 21- 986 an...

Review Period Set for Medtronic Pacemakers

05/25/2007

Federal Register Notice: FDA has determined the regulatory review period for Medtronic Inc.’s KDR 401 and 403 pacemakers is ...

Fosrenol Review Period Set

05/22/2007

Federal Register Notice: FDA has determined the regulatory review period for Shire’s Fosrenol is 2,449 days for the extendin...

Science Board to FDA to Meet

05/21/2007

Federal Register Notice: FDA’s Science Board will meet 6/14, from 8 a.m. to 4 p.m. at the Holiday Inn Gaithersburg, 2 Montgo...

Info on Marketing Applications Sent to OMB

05/21/2007

Federal Register Notice: FDA has submitted a proposed collection of information, Guidance for Industry on Continuous Marketing App...

Review Period Set for Noxafil

05/21/2007

Federal Register Notice: FDA has determined the regulatory review period for Schering Corp.’s Noxafil (posaconazole) is 3,65...