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Docket Number Added in Dental Panel Notice

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Federal Register Notice: FDA amends a 6/11 notice on the upcoming meeting of the Dental Products Panel to add a docket number to A...

CDRH Adds Advertising and Policy Staff

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CDRH ramps up its Office of Compliance promotion and advertising staff, adding two regulatory reviewers to help tackle the workloa...

FDA Approves Allergan's Eye Drug Ozurdex

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FDA approves an Allergan NDA for Ozurdex (dexamethasone intravitreal implant) 0.7 mg for treating non-infectious ocular inflammati...

CVM Workshop to Provide Electronic Submission Tool

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Federal Register Notice: FDA plans a public workshop 10/21 to provide access to the animal health industry CVMs electronic submiss...

FDA Reiterates Dental Handpiece Burn Alert

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FDA says it continues to be concerned about the potential for patient burns due to overheating dental handpieces.

Amgen Recalls Epogen and Procrit Lots Over Glass Particulates

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Amgen recalls certain lots of its anemia therapies Epogen and Procrit (epoetin alfa) vials due to the potential for the products t...

'Orphan' Status for Lymphoma Drug

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FDA grants an orphan drug designation to ZioPharm Oncology, Inc. for Zinapar (darinaparsin) for treating peripheral T-cell Lymphom...

Avandia Stays on the Market Under Restrictions

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FDA says GlaxoSmithKlines Avandia can remain on the market but the company must develop a REMS that sharply restricts its use to c...

Roche Offers Criteria for IND Combinations

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Roche says FDA should consider two criteria in determining whether to permit two or more new molecular entities in combination dru...

FDA Reviewing AstraZeneca NDA for Thyroid Cancer Drug

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FDA accepts for review an AstraZeneca NDA for its investigational drug vandetanib, indicated for treating patients with advanced m...