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Comments Sought on HCT/P Establishments

03/11/2010

Federal Register Notice: FDA is seeking public comment on the information collection requirements for FDA regulations related to h...

Comments Sought on Mammography Quality Requirements

03/11/2010

Federal Register Notice: FDA is seeking comments on the estimated reporting and recordkeeping burden associated with the Mammograp...

15 Drug Products Not Withdrawn for S&E

03/11/2010

Federal Register Notice: FDA has determined that 15 drug products were not withdrawn from sale for reasons of safety or effectiven...

Panel to Discuss Bioequivalence, Phospholipidosis

03/11/2010

Federal Register Notice: FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will meet 4/14, from ...

FDA OKs Ivy Labs 3 ANADAs for Heifer Feed

03/11/2010

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of three Ivy Laboratories ANADAs that...

Benzoyl Peroxide is GRASE for OTC Acne Products

03/04/2010

Federal Register Final rule: FDA is issuing a final rule to include benzoyl peroxide as a generally recognized as safe and effecti...

FDA Debars Holland, Denies Hearing

03/04/2010

Federal Register Notice: FDA is denying James A. Holland’s request for a hearing and is issuing an order under the Federal F...

Guidance on Materials Used to Produce Viral Vaccines

03/04/2010

Federal Register Notice: FDA is making available a document, Guidance for Industry: Characterization and Qualification of Cell Sub...

Reorganization of Office of the Commissioner Republished

02/19/2010

Federal Register Notice: FDA is announcing the reorganization of the Office of the Commissioner, which was previously published in...

FDA Clarifies Falsification of Data Reporting

02/19/2010

Federal Register Proposed rule: FDA is proposing to amend its regulations to require sponsors to report information indicating tha...