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QS Violations Detailed at 2 Navilyst Facilities

[ Price : $8.95]

FDAs New York District Office warns Navilyst Medical about Quality System violations at two facilities that are specification deve...

FDA Safety Alert on New Biogen MS Drug

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FDA issues a drug safety alert on Biogen Idecs new multiple sclerosis drug Tecfidera (dimethyl fumarate) after the company confirm...

Global Drug Spend on the Rise Next 5 Years: IMS

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A new IMS Health reports says that global drug spending is forecast to grow at a 4-7% compound annual rate over the next five year...

Industry Faults FDA Refuse to Receive ANDA Guidance

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The Generic Pharmaceutical Association and other commenters say an FDA proposal to refuse to receive an ANDA due to lack of justif...

Teva Adds Info to Copaxone Petition

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Teva submits more supplementary information to support a petition asking FDA not to approve any ANDA for a Copaxone generic unless...

Customed Class 1 Recall of Surgical Kits

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Customed, Inc. begins a Class 1 recall of its sterile convenience surgical kits-trays because they have a potential package integr...

Advisors Reject Stronger Steroid Injection Warnings

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Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee recommend that FDA call for a targeted contraindicati...

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Federal Register Notice: FDA releases a revised draft guidance: Electronic Product Reporting for Human Drug Compounding Outsourcin...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