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U.S. Should Protect Drug Innovation: Associations

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The trade associations for branded and generic drugs urge the U.S. Trade Representative to use the 2022 Section 301 review to take...

FDA Withdraws 29 No-Longer-Marketed NDAs

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Federal Register notice: FDA withdraws approval of 29 NDAs from multiple applicants because they are no longer marketed.

8 ANDAs Withdrawn by FDA

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Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they notified the agency that the dr...

Kite Labeling Update on Yescarta with Corticosteroids

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FDA approves a Kite labeling update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophy...

Cardinal Health Paying $13 Million for Kickback Scheme

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The Justice Department says whistleblowers will receive about $2.6 million from a $13 million Cardinal Health settlement of charge...

CDER Releases 2022 Guidance Agenda

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CDER releases a list of 98 new and revised draft guidances intended for publication in 2022.

VySpine Cervical Interbody Fusion Device Clears

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FDA clears a VySpine 510(k) for the ClariVy Cervical IBF System and its use in anterior cervical discectomy with fusion procedures...

Empowered Covid-19 Test Recall is Class 1

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FDA says the Empowered Diagnostics recall of more than 250,000 unapproved Covid-19 tests is Class 1.

Blackstone Labs Founder Gets 54 Months on Steroids Charges

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A Florida federal judge sentences the founder of Blackstone Labs to 54 months in prison and orders him to forfeit $2.9 million for...

FDA Releases 4 Guides on Real-World Data/Evidence

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FDA posts four draft guidances on the use of real-world data and real-world evidence in regulatory decision-making, covering topic...