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Firm Gets Breakthrough Status for Prostate Cancer Test

[ Price : $8.95]

FDA grants Cleveland Diagnostics a breakthrough device designation for the IsoPSA Assay, a prostate cancer diagnostic test.

Nonvoting Rep Sought for Tobacco Science Panel

[ Price : $8.95]

Federal Register notice: FDA requests nominations for a nonvoting representative to serve on the Tobacco Products Scientific Advis...

FDA Sets Record in Generic Drug Approvals

[ Price : $8.95]

FDA acting commissioner Ned Sharpless says FDA has set a record for generic drug approvals in FY 2019.

FDA Tobacco Ad Rule Violates 1st Amendment: WLF

[ Price : $8.95]

Washington Legal Foundation cites a drug advertising court case in arguing that a proposed FDA tobacco labeling rule violates the ...

PDUFA User Fee Waiver Guidance

[ Price : $8.95]

FDA issues a revised guidance on PDUFA user fee waivers, reductions, and refunds.

H.R. 3 Amendments Not Enough: Public Citizen

[ Price : $8.95]

Public Citizen says new amendments to the House drug price legislation are an improvement but dont go far enough.

Lilly Cancer Drug Misses Endpoint

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Lilly says its pancreatic cancer drug misses its primary endpoint in a Phase 3 trial.

HHS Inspector General Assessing Device Surveillance

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HHSs Office of Inspector General says it is assessing FDAs medical device postmarket surveillance activities.

ViiV sNDA for Dovato as a Switch Treatment

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ViiV Healthcare submits a supplemental NDA for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection.

Improving Dental Device 510(k) Submissions

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A CDRH Webinar discusses issues seen in dental device 510(k) submissions and ways in which they can be improved.