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New FDA Warning on Power Morcellators for Hysterectomies

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FDA issues an updated warning against using laparoscopic power morcellators to remove the uterus (hysterectomy) or fibroids (myome...

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 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.

3 Guidances for Drug Compounding Outsourcing Facilities

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FDA issues three additional guidance documents to assist firms that compound sterile human drugs with registering as outsourcing f...

Allow Links to Risk Info in Social Media Promos, Groups Argue

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Comments on FDAs social media promotions guidance urge the agency to allow direct links to side effect information.

Comments Sought on Animal Food/Feed Prohibited Substances

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Federal Register Notice: FDA seeks comments on recordkeeping for animal food/feed prohibited substances.