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Comments Sought on Vinpocetine

[ Price : $8.95]

Federal Register Notice: FDA requests comments on the regulatory status of vinpocetine.

Bausch & Lomb Inspection FDA-483 Out

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FDA releases an FDA-483 from a Bausch & Lomb inspection in Tampa, FL, last February.

Data Integity, CGMP Issues at Zhejiang Hisoar

[ Price : $8.95]

FDA warns Chinas Zhejiang Hisoar Pharmaceutical Co. about CGMP and data integrity concerns in manufacturing active pharmaceutical ...

Judge Allows 3 Liability Claims Against Invokana

[ Price : $8.95]

Ruling against federal preemption, a Louisiana federal court allows three state law product liability claims against Janssens Invo...

Comments Sought on Device Fellowship Program

[ Price : $8.95]

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FDA Finds 25 Drug Products Not Withdrawn for S&E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Federal Register Notice: FDA determines that 25 drug products were not withdrawn for sale for reasons of safety or effectiveness.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...