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FDA Guidance on Developing Drugs for Acute Migraine

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FDA posts a draft guidance on Migraine: Developing Drugs for Acute Treatment that is intended to assist sponsors in their migraine...

Covidien Class 1 Recall of Defibrillator Electrodes

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Covidien begins a Class 1 recall of its Medi-Trace Cadence and Kendall Defibrillation Electrodes because they do not work with Phi...

FDA Dims LASIK Harms it Found in Life Quality Study

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In a long-awaited report on the post-surgical quality of LASIK patients, FDA downplays the harms it found in up to 45% of 572 pati...

Spectrum Pharma Petitions FDA to Block Fusilev Generics

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Spectrum Pharmaceuticals petitions FDA asking that it not approve any ANDAs that seek to carve-out Fusilevs orphan drug exclusivit...

Comments Sought on Blood CGMPs

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Federal Register Notice: FDA seeks comments on a proposed collection of information on CGMP requirements for blood and blood compo...

Soto Debarred

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Federal Register Notice: FDA issues an order debarring Kelvin Soto for a period of six years from any contact to a person with an ...

Guidance on Veterinary CMC Data Submissions

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Federal Register Notice: FDA releases a draft guidance: Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections...

Lawmakers Ask HHS for Insight into Rising Generic Drug Prices

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Sen. Bernie Sanders (I-VT) and Rep. Elijah E. Cummings (D-MD) write HHS secretary Sylvia Burwell asking her to address significant...

How to Avoid a Hold on Device eCopy Submissions

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CDRH posts a resources listing for medical device makers submitting an electronic copy of their submissions.

Hospira Recalls 1 Lidocaine Lot

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Hospira recalls one lot of 1% lidocaine HCl for injection due to a confirmed customer report about particulate in a single unit.