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Guidance on Immunoglobulin Antibody Collection

10/20/2005

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Recommendations for Implementing...

Anesthetic and Life Support Drugs Panel to Meet

10/20/2005

Federal Register Notice: FDA’s Anesthetic and Life Support Drugs Advisory Committee will meet 11/10, from 9 a.m. to 5 p.m. at CDER...

Guidance on Electronic Submissions with eCTD Specs

10/19/2005

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

Comments Sought on IND Regulations

10/12/2005

Federal Register Notice: FDA is seeking comment on requirements under which the clinical investigation of the safety and effective...

Comments Sought on Puberty Disorder Research

10/07/2005

Federal Register Notice: The HHS Office for Human Research Protections, Office of Public Health and Science and FDA are soliciting...

Subcommittee to Discuss Puberty Disorder Test

10/07/2005

Federal Register Notice: The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee of FDA will meet 11/15 to discuss a...

Pediatric Panel to Discuss Obesity, Puberty Disorders

10/07/2005

Federal Register Notice: FDA’s Pediatric Advisory Committee will meet 11/16, from 8 a.m. to 6 p.m., and 11/17, from 8 a.m. to 5 p....

Extralabel Animal Drug Use Info Sent to OMB

09/28/2005

Federal Register Notice: FDA’s proposed collection of information entitled, “Extralabel Drug Use in Animals — 21 CFR Part 530” has...

Info on Veterinary Feed Directive Sent to OMB

09/28/2005

Federal Register Notice: FDA’s proposed collection of information entitled “Veterinary Feed Directive — 21 CFR Part 558” has been ...

Info on Unapproved Uses Sent to OMB

09/28/2005

Federal Register Notice: FDA’s proposed collection of information entitled “Dissemination of Information on Unapproved/New Uses fo...