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FTC Expands Junk Patent Challenges

[ Price : $8.95]

The Federal Trade Commission says it is expanding its challenges to junk drug patents with warnings to 10 companies about over 300...

Thiopurine Alert on Intrahepatic Cholestasis of Pregnancy

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FDA issues a safety alert on the rare risk of intrahepatic cholestasis of pregnancy associated with the use of thiopurines (azathi...

OND 55 Drug Approvals in 2023

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The CDER Office of New Drugs says it participated in 55 novel drug approvals in 2023.

Pfizer Gets Traditional Approval for Tivdak

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FDA gives Pfizer traditional approval for its previously accelerated-approved Tivdak (tisotumab vedotin-tftv) for recurrent or met...

Info Collection on FDA Recall Regs

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Federal Register notice: FDA sends to OMB an information collection extension entitled FDA Recall Regulations 21 CFR Part 7....

Listening Session on Advisory Committee Revamp

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Federal Register notice: FDA announces a 6/13 virtual public meeting entitled Listening Session: Optimizing FDAs Use of and Proces...

QS Violations in Unapproved Spectrum Devices

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FDA warns the UKs Spectrum Medical about QS violations in its production of unapproved perfusion system devices.

VITEK 2 Antimicrobial Test Cards Recalled

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BioMrieux recalls its VITEK 2 AST antimicrobial sensitivity testing cards due to a higher concentration of ceftriaxone antibiotic ...

Draft Guide on Cell/Gene Therapy Considerations

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Federal Register notice: FDA makes available a draft document entitled Considerations for the Use of Human- and Animal-Derived Mat...

Guide on Composition and Ingredient Statements

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Federal Register notice: FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and AN...