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FDA Seeks Ban on OTC Skin Bleach Drugs

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Federal Register Proposed rule: FDA issues a notice of proposed rulemaking to establish that OTC skin bleaching drug products are ...

FDA to Reorganize Registration and Listing Regs

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Federal Register Proposed rule: FDA proposes to reorganize and clarify its regulations on drug establishment regulation and drug l...

Guidance on Emergency Research

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Federal Register Notice: FDA releases a draft guidance for conducting emergency research for IRBs, clinical investigators and spon...

FDA Plans Hearing on Emergency Research

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Federal Register Notice: FDA plans a public meeting 10/1 in Rockville, MD on emergency research conducted without informed consent...

Info on User Fee Cover Sheet Sent to OMB

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Federal Register Notice: FDA submits to OMB a collection of information on the user fee cover sheet.

Comments Sought on Device Small Business Qualifications

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Federal Register Notice: FDA seeks comments on a collection of information permitting a device applicant to certify that it qualif...

Minor Changes to Advisory Panel Notice

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Federal Register Notice: FDA makes minor corrections to the notice of the meeting of the Cardiovascular and Renal Drugs Advisory C...

Advisory Panel Session Canceled

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Federal Register Notice: FDA cancels the 9/7 meeting of the Psychopharmacologic Drugs Advisory Committee.

Allergenic Products Panel to Meet

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Federal Register Notice: FDAs Allergenic Products Advisory Committee will meet 9/13 to discuss reclassifying Category IIIA allerge...

Clinical Pharmacology Subcommittee to Meet

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Federal Register Notice: FDAs Clinical Pharmacology Subcommittee will meet 10/18 in Rockville, MD.