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Drug Recalls Dropped in 2nd Quarter

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Stericycle says that in the second quarter of this year drug recalls dropped and medical device recalls increased.

Insys Therapeutics Agrees to $150 Million Fine with DoJ

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Insys Therapeutics reaches an agreement in principle with the Department of Justice to pay $150 million to settle a civil and crim...

FDA Clears iCADs Latest Breast Density Software

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FDA clears an iCAD 510(k) for its latest artificial intelligence software solution PowerLook Density Assessment Version 3.4 for b...

AstraZeneca Settles Texas Medicaid Suits for $110 Million

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Texas attorney general Ken Paxton says AstraZeneca will pay the state $110 million to settle suits over fraudulent Medicaid market...

Dissolution Testing and Acceptance Criteria Guidance

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FDA issues a guidance with recommendations for submission of NDAs, INDs, or ANDAs for orally administered immediate-release drug p...

FDA Approves First CGT Generic Drugs

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FDA uses the Competitive Generic Therapy pathway to approve several strengths of Apotex potassium chloride solution.

Rupture of Membranes Tests Have Limits: FDA

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FDA cautions healthcare professionals not to rely on rupture of membranes tests alone and instead use them as part of a broader cl...

Qiagen Sciences Recalls Membrane Rupture Test

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Qiagen Sciences recalls the AmniSure ROM Test due to a potential manufacturing defect causing the control line to not display.

27 ANDAs Being Withdrawn by FDA

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Federal Register notice: FDA withdraws 27 ANDAs from multiple applicants after the application holders told the agency that the dr...

CGMP Deviations at Les Produits Chimiques

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FDA warns Canadas Les Produits Chimiques about deviations from CGMP regulations for active pharmaceutical ingredients.