Abigail Butler

Faegre Drinker Biddle & Reath LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA Aligns Quality Systems Regulation With International Standards

After publishing the proposed regulation nearly two years ago, the FDA has issued its final rule that will make its regulatory framework more closely aligned with the international framework used by many other regulatory...more

2/7/2024 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry

FDA Proposal Set to Align Quality Systems Regulation With International Standards

The FDA has recently published a proposed regulation that will make its regulatory framework more closely aligned with the international framework used by other regulatory authorities around the world. If finalized, this...more

2/28/2022 / CGMP , Food and Drug Administration (FDA) , Medical Devices , Proposed Regulation

New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction...more

6/24/2021 / Appeals , Consumer Fraud , Food and Drug Administration (FDA) , Homeopathic Remedies , Manufacturers , Pharmaceutical Industry , Preliminary Injunctions , Prescription Drugs , Regulatory Standards , Subject Matter Jurisdiction

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