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$2 Million FDA Grant to Marker Therapeutics

[ Price : $8.95]

FDA grants $2 million to Marker Therapeutics to support the treatment arm in a Phase 2 trial of its T-cell candidate to treat pati...

Preserve Access to Compounded Hormones: APC

[ Price : $8.95]

The Alliance for Pharmacy Compounding calls on FDA to reject recommendations in a National Academies report and instead maintain p...

Draft Guide on Device Maker Computer Software Assurance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Computer Software Assurance for Production and Quality Syst...

Right to Try Annual Summary Reporting Rule

[ Price : $8.95]

FDA publishes a final rule setting a new deadline for the annual summary report required under the Right to Try Law.

ISCT Criticizes Ruling in Cell, Gene Therapy Case

[ Price : $8.95]

The International Society for Cell & Gene Therapy says a federal court decision that FDA cannot regulate cell therapy products as ...

New OND Research Web Page

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FDA launches a new Web page to highlight CDER Office of New Drugs regulatory science research activities.

FDA Withdraws Merck NDA for Vioxx

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Federal Register notice: FDA withdraws approval of a Merck NDA for arthritis drug Vioxx (rofecoxib).

FDA Report on Generic Drug Approval Cost Savings

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An FDA report says generic drug approvals in 2018-2020 led to billions of dollars in savings.

FDA in Pistoia Alliance Working Group

[ Price : $8.95]

CDER representatives will participate in an In Vitro Pharmacology working group being assembled by Pistoia Alliance.

User Fee Reauthorization Talks Continue

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Congressional negotiations on FDA user fee reauthorization are continuing, with some major changes in play, according to Politico....