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Several Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that several drug products were not withdrawn from sale for reasons of safety or effective...

FDA OKs TWi Pharmas Generic Aricept

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FDA grants final approval to TWi Pharmaceuticals for its ANDA for a generic version of Eisais Aricept, 23 mg to treat Alzheimers d...

Revive Plans Trial for Bucillamine in Gout Patients

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Revive Therapeutics files an IND to FDA for REV-002 (bucillamine) for treating gout.

FDA Approves AstraZenecas Xigduo XR for Diabetes

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FDA approves an AstraZeneca NDA for once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for treating...

Biosimilar Patent Dance Problems Seen: Attorney

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Attorney Kurt Karst says an Amgen complaint against Sandoz over a biosimilar version of Neupogen is demonstrating difficulties fou...

Many Laws, Regulations Affect mHealth Devices: Lawyers

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A Foley & Lardner online report says developers of mHealth mobile technologies must be aware of the many laws and regulations that...

More Criticism of Risk Info Guidance

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Public comments continue to criticize an FDA draft guidance on disseminating risk information to healthcare providers for either v...

Petition Seeks Cipro Indication Restrictions

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A citizen petition asks FDA to order extensive prescribing limitations for Cipro due to adverse events seen in post-marketing expe...

First Custom Design Exemption Report Due in March

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A CDRH Webinar on a recent custom design exemption guidance confirmed that the first annual report mandated by the guidance is due...

Takeda Court Filing Questions FDAs Mitigare Approval

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A Takeda court filing says FDAs approval of Hikma Pharmaceuticals 505(b)(2) application last month for Mitigare (colchicine) was a...