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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...

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Federal Register Notice: FDA releases a draft guidance: Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections...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

CDER Already Surpasses NME Approval Totals for Last Year

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CDER eclipses last years 27 new molecular entity (NME) drug product approvals by approving 34 applications through 10/15.

FDA Panel Backs Novartis Drug for Plaque Psoriasis

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FDAs Dermatologic and Ophthalmic Drugs Advisory Committee votes 7 to 0 to support the approval of Novartis AIN457 (secukinumab) fo...

FDA Accepts Merck, Sanofi Pediatric Vaccine BLA

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FDA accepts for review a Merck and Sanofi Pasteur BLA for their investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1.