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Guide on Complex Innovative Clinical Trial Designs

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Federal Register notice: FDA makes available a draft guidance entitled Interacting with the FDA on Complex Innovative Clinical Tri...

2 Lots of Quinacrine Dihydrochloride API Recalled

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Darmerica recalls two lots of quinacrine dihydrochloride bulk active pharmaceutical ingredient due to a label mix-up.

Comments Sought on Developing CNS Stimulants

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Federal Register notice: FDA seeks comments on development and evaluation of abuse-deterrent formulations of central nervous syste...

Device Guidances Under Safety/Performance Pathway

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Federal Register notice: FDA makes available several device-specific draft guidance documents for the agency device Safety and Per...

Pilot on Device Conformity Assessment Program

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FDA releases a draft guidance entitled Pilot Accreditation Scheme for Conformity Assessment Program that outlines goals, scope, pr...

Novo Nordisk GLP-1 Approved for Diabetes

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FDA approves Novo Nordisks Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with Type 2 dia...

Senate Committee OKs $80 mil. FDA Spending Boost

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The Senate Appropriations Committee approves an FY 2020 FDA appropriations bill, which includes $3.148 billion in discretionary fu...

New Packaging OKd to Reduce Loperamide Abuse

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FDA approves package size and package type limits for over-the-counter forms of loperamide, indicated for controlling symptoms of ...

Former FDA Device Head Villforth Passes

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Former CDRH director John C. Villforth passes at the age of 88.

FDA Proposes Rule on E-cigarette Pathway

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FDA issues a proposed rule setting requirements related to the content, format and review and communications procedures for premar...