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Panels to Discuss Trials for Bacterial Diseases

03/05/2007

FDA OKs Pfizer NADAs for Canine Vomiting

03/01/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of two Pfizer NADAs that provide for ...

FDA OKs Ivy Labs Tylosin Combo Implant

03/01/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Ivy Laboratories, Division of I...

FDA OKs Intervet sNADA

03/01/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Intervet supplemental NADA that...

FDA, AdvaMed Sponsor Seminars on Device Regs

03/01/2007

Federal Register Notice: CDRH and the Office of Regulatory Affairs in cooperation with AdvaMed's Medical Technology Learning Insti...

FDA OKs Elanco Monensin Labeling Revisions

03/01/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Elanco Animal Health supplement...

Info on Premarket Notification Sent to OMB

02/28/2007

Federal Register Notice: FDA has submitted a proposed collection of information, “Premarket Notification — 21 CFR Part...

Guidance on Cell/Tissue Donor Eligibility

02/28/2007

Federal Register Notice: FDA is making available the Guidance for Industry: Eligibility Determination for Donors of Human Cells, T...

Guidance on Advisory Committee Briefing Material

02/28/2007

Federal Register Notice: FDA is making available a draft guidance for industry entitled Advisory Committee Meetings — Prepar...

Review Period Set for Novartis’ Exjade

02/23/2007

Federal Register Notice: FDA has determined the regulatory review period for Novartis’ Exjade (deferasirox) is 2,288 days fo...