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FDA Issues EUA for Ebola Diagnostic

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Federal Register Notice: FDA issues an Emergency Use Authorization for a in vitro diagnostic for detecting the Ebola Zaire virus.

Guidance on Provisional Tobacco Product Enforcement

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Federal Register Notice: FDA releases a guidance: Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not...

Panel to Discuss Organon NDA

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Federal Register Notice: FDAs Anesthetic and Analgesic Drug Products Advisory Committee will meet 11/6 to discuss an Organon USA N...

Pharmacyclics sNDA for Imbruvica Submitted

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Pharmacyclics files a supplemental NDA for Imbruvica (ibrutinib) for front-line use in patients with chronic lymphocytic leukemia.

Public Meeting on Drug Interactions with Contraceptives

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Federal Register Notice: FDA plans a public meeting 11/9: Drug Interactions with Hormonal Contraceptives (HCs): Public Health and ...

FDA Accepts Dimension IND for Hemophilia Drug

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FDA accepts a Dimension Therapeutics IND for a clinical study to evaluate DTX101 in adult patients with moderate/severe to severe ...

Allergan Gains 3 Generic Mucinex Approvals

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Allergan gains FDA approval for three ANDAs for three generic Mucinex products.

Panel Votes Down New Purdue Painkiller

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FDAs Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee vote 23 to 1...

GPhA Says FDA Oversteps Authority on Tablet Size Concerns

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The Generic Pharmaceutical Association says FDA has no scientifically-supported safety or efficacy concern that would require it t...

Amgen sNDA for Repatha Single-dosing Option

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Amgen submits a supplemental NDA seeking approval for a single-dosing option for monthly administration of Repatha (evolocumab) In...