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Guidance on Electronic Labeling Submissions

04/21/2005

Federal Register Notice: FDA is making available a guidance for industry entitled Providing Regulatory Submissions in Electronic F...

Panel to Discuss Pulse Oximeters

04/21/2005

Federal Register Notice: FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committe...

Guidance on Blood Donor Suitability and West Nile Virus

04/20/2005

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Assessing Donor Suitability and ...

Info on Investigational Animal Drugs Sent to OMB

04/20/2005

Federal Register Notice: FDA is announcing that a proposed collection of information entitled, “New Animal Drugs for Investi...

Info on AERs for Biologics Sent to OMB

04/20/2005

Federal Register Notice: FDA is announcing that a proposed collection of information entitled, “Adverse Experience Reporting...

Comments Sought on CDRH Web Site Survey

04/20/2005

Federal Register Notice: FDA is seeking public comment on the proposed collection of information on a survey of customers who shou...

Public Meeting on Levothyroxine Sodium Equivalence

04/20/2005

Federal Register Notice: FDA is holding a public meeting 5/23 on the therapeutic equivalence of levothyroxine sodium drug products...

Boehringer’s HIV Drug to Go before FDA Panel

04/11/2005

Federal Register Notice: FDA’s Antiviral Drugs Advisory Committee will meet 5/19, from 8 a.m. to 5 p.m. at the Hilton Washin...

Panel to Discuss Tibotec NDA for Zarnestra

04/11/2005

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 5/5, from 8:30 a.m. to 4:30 p.m. at FDA, CDER Co...

Panel to Discuss Cervical Imaging System

04/11/2005

Federal Register Notice: FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet 5...