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Rep. Bilirakis Introduces Orphan Drug Exclusivity Extension Bill

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U.S. Rep. Gus Bilirakis (R-FL) introduces H.R. 5750, the Orphan Product Extensions Now Accelerating Cures & Treatment Act, which w...

FDA Guidance on Design Considerations for Home-use Devices

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FDA posts a new guidance on Design Considerations for Devices Intended for Home Use that is intended to assist manufacturers in de...

Comments Sought on Clinical Trial Subgroup Posting

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Federal Register Notice: FDA requests comments on a new posting on the agencys Web site: Subgroup Data for FDA Approved Products, ...

Guidance on Fees for Compounding Facilities

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Federal Register Notice: FDA releases a guidance: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 7...

Guidance on E-Reporting for Compounding Outsourcing Facilities

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Federal Register Notice: FDA releases a revised draft guidance: Electronic Product Reporting for Human Drug Compounding Outsourcin...

Workshop Slated on Laboratory Developed Tests

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Federal Register Notice: FDA plans a public workshop 1/8-9/15 on the framework for regulatory oversight of laboratory developed te...

Guidance on Registration of Drug Compounding Facilities

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Federal Register Notice: FDA releases a final guidance: Registration of Human Drug Compounding Outsourcing Facilities Under Sectio...

FDA Denies Allergan Petition on Restasis Bioequivalence

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FDA denies an Allergan petition asking FDA to not accept or approve any ANDAs for its Restasis (cyclosporine ophthalmic emulsion) ...

FDA Orphan Designation for Duchenne Therapy

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FDA grants Catabasis Pharmaceuticals an orphan drug designation for CAT-1004 for treating Duchenne muscular dystrophy.

Panel to Discuss Astellas NDAs for Aspergillosis/Mucormycosis

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 1/22/15 to discuss Astellas Pharma NDAs for treati...