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Device Export Foreign Approval Letters Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Export of Medical Devices; Foreign Let...

Susceptibility Test Interpretive Criteria Updates

[ Price : $8.95]

Federal Register notice: FDA is announcing the availability of its annual compilation of update notices related to the agencys Sus...

Lilly Scraps Lupus Development Program

[ Price : $8.95]

Eli Lilly says it is discontinuing its Phase 3 development program for JAK inhibitor Olumiant (baricitinib) in adults with active ...

Another Sponsor Quits Over Post-marketing Study Disagreement

[ Price : $8.95]

Joining Incyte in withdrawing an NDA over a confirmatory study disagreement, Regeneron Pharmaceuticals and Sanofi withdraw their s...

Is FDA Commissioner Nominee in Jeopardy?

[ Price : $8.95]

FDA commissioner nominee Robert Califfs chances of passing a Senate vote narrow as he reportedly loses some Senate backing and the...

Guide on Revising ANDA Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Revising ANDA Labeling Following Revision of the RLD Labeli...

Guide on ANDA Info Requests/Review Letters

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Federal Register notice: FDA makes available a final guidance entitled Information Requests and Discipline Review Letters Under GD...

Rx Drug Use Up, Spending Down: CBO

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A Congressional Budget Office report says that although consumer use of prescription drugs has increased between 2009 and 2018, av...

Emergent BioSolutions EIR and FDA-483

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FDA releases an FDA-483 and EIR from a 2019 inspection at Winnipeg, Manitoba-based Emergent BioSolutions Canada.

Hopkinton Drug Notice of Violation

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FDA cautions Hopkinton Drugs about deficiencies in its practices for producing drug products that put patients at risk.