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FDA Sends Info on Aluminum in Parenterals to OMB

05/25/2006

Federal Register Notice: FDA’s proposed collection of information "Aluminum in Large and Small Volume Parenterals Used in Total Pa...

Comments Sought on User Fee Cover Sheet

05/25/2006

Federal Register Notice: FDA is seeking public comment on the User Fee Cover Sheet; Form FDA-3397 that must be submitted along wit...

OMB OKs Info on Clinical Investigator Disclosures

05/25/2006

Federal Register Notice: FDA’s collection of information entitled "Financial Disclosure by Clinical Investigators" has been approv...

Info OK’d on Filing Objections/Requests for Hearings

05/25/2006

Federal Register Notice: FDA’s collection of information entitled "Filing Objections and Requests for a Hearing on a Regulation or...

Q8 Pharmaceutical Development Guidance Out

05/22/2006

Federal Register Notice: FDA is making available a guidance, Q8 Pharmaceutical Development, prepared under the auspices of the Int...

OMB OKs Info on Focus Groups

05/22/2006

Federal Register Notice: FDA’s collection of information entitled "Focus Groups as Used by the Food and Drug Administration" has b...

Comments Sought on Influenza A Virus Guidance

05/22/2006

Federal Register Notice: FDA is seeking public comment on Guidance on Reagents for Detection of Specific Novel Influenza A Viruses...

Guidance on Pediatric Referrals to FDA

05/10/2006

Federal Register Notice: FDA is making available a draft guidance entitled Guidance for Industry; Process for Handling Pediatric R...

Public Prep Meeting for ICH Meetings

04/20/2006

Federal Register Notice of meeting: FDA is scheduling 5/8 a public meeting entitled "Preparation for ICH meetings in Yokohama, Jap...

Guidance on Gamma Irradiation of Blood Withdrawn

04/10/2006

Federal Register Notice: FDA is withdrawing a guidance, Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A ...