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7th Circuit Backs Dismissal of AbbVie False Claims Suit

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The 7th Circuit Court of Appeals affirms, although for different legal reasons, a federal district court ruling rejecting a False ...

FDA Seeks Comments on Pregnant Women in Trials

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FDA reminds companies and the public that they have until 9/19 to submit comments on a draft guidance entitled E21 Inclusion of Pr...

Microbot Single-Use Robotic Endovascular System Cleared

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FDA clears a Microbot Medical 510(k) for its Liberty Endovascular Robotic System, a single-use, remotely operated device for perip...

MAHA Reports Aims to Improve Kids Health

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A MAHA Commission report assessing the health of American children suggests a couple of ways in which FDA could improve the situat...

CGMP API Deviations at Hikal Limited

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FDA warns Jigani, Karnataka, India-based Hikal Limited about CGMP deviations in its production of active pharmaceutical ingredient...

Issues in 3 Trials Conducted by Detroit Doctor

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FDA warns Detroit, MI-based medical oncologist Shirish Gadgeel about bioresearch monitoring violations in his conduct of three cli...

Former CBER Therapeutics Deputy Anatol Joins Lilly

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Eli Lilly hires former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her agency p...

FDA Posts 2 Biosimilar Development Guides

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FDA releases two final guidances related to biosimilar development: One on comparative analytical assessments, and the other on cl...

Firm Pays $40 Million Over Adulterated Gowns

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Kimberly-Clark agrees to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adultera...

Gottlieb Warns HHS Could Undermine Pediatric Vaccines

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Former FDA commissioner Scott Gottlieb warns that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report ...