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Comments Sought on Device Fellowship Program

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Federal Register Notice: FDA seeks comments on the application for the Medical Device Fellowship Program.

Info on Product Jurisdiction Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information, Product Jurisdiction: Assignment of Agency Component fo...

FDA Finds 25 Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that 25 drug products were not withdrawn for sale for reasons of safety or effectiveness.

FDA Establishes Antiseptic Ingredients Are Not GRAS/E

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Federal Register Final rule: FDA establishes that certain active ingredients used in over-the-counter antiseptic products intended...

FDA Extends Review of Novo Nordisk Diabetes Drug Combo

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FDA extends by three months the review of a Novo Nordisk NDA for IDegLira, a fixed-dose combination of Victoza (liraglutide), a gl...

AstraZeneca Positive Data on Asthma Add-on Therapy

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AstraZeneca says recent Phase 3 data demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exac...

FDA Mulls Harmonized Device Review System: Shuren

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CDRH director Jeffrey Shuren says FDA and other international regulatory agencies are considering how to develop a harmonized prem...

Quality, Data Issues in Pan Drugs Inspection

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FDA warns Indias Pan Drugs about CGMP and data integrity violations in its manufacturing of finished pharmaceuticals.

BD Submits PMA for Onclarity HPV Assay

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BD submits a PMA application to FDA for its Onclarity HPV (human papilloma virus test.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Central Admixture Pharmacy Services, Healing Noni Co., Healing-Scents, Jack P. H...