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GMP Inspection Causes FDA Denial of Valeant Eye Drug

[ Price : $8.95]

FDA issues Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an ...

GEs Signa Premier MRI for Brain Injury Detection Cleared

[ Price : $8.95]

FDA clears a GE Healthcare 510(k) for the Signa Premier, a new wide bore 3.0T magnetic resonance imaging system.

New DTC Research Examines New Risk Presentation Model

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New research by FDA and RTI Internationals Center for Communication Science shows promising data on a new model for presenting ris...

48 ANDA Bioequivalence Guidances Published

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Federal Register notice: FDA announces the availability of 48 final product-specific guidances that recommend the design of bioequ...

Oncologic Drugs Panel to Review Sutent sNDA

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Federal Register notice: FDA announces a 9/19 Oncologic Drugs Advisory Committee meeting to review a C.P. Pharmaceuticals suppleme...

Teva Gains Approval for new Qvar RediHaler

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FDA approves a Teva Pharmaceutical Industries NDA for Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breat...

Vaccines Panel to Review Glaxo Zoster Vaccine

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Federal Register notice: FDA announces a 9/13 Vaccines and Related Biological Products Advisory Committee meeting that will review...

Vernalis Gets Complete Response on Rx Cough-Cold NDA

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FDA issues Vernalis a complete response letter on its NDA for CCP-08, an undisclosed extended-release product being developed for ...

Nature Editorial Urges Academic Scientists to Help FDA

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A Nature editorial says FDA needs help from academic scientists to review and approve new drug therapies because in-house talent i...

FDA Clears Mauna Kea Confocal Miniprobes

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FDA clears a Mauna Kea Technologies 510(k) for its CelioFlex UHD Confocal Miniprobes for use with the companys Cellvizio laser end...