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DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution

FDA Law Blog: Biosimilars

Hull A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agencys approach to crediting one experts testimony over that of another expert during an administrative hearing. The hearing involved dueling expert testimony on the pharmacy standard of care in Louisiana from both DEA and the respondent.

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Salt Lake City

Alta Sciences

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Gretchen Green

Alta Sciences

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HP&M Counsel John Claud Provides Testimony to House Subcommittee on FDA Foreign Inspections

FDA Law Blog: Biosimilars

Mr. Claud was joined in his testimony by Mary Denigan-Macauley , a Director for Health Care at the Government Accountability Office (GAO) and Dinesh Thakur. Mr. Claud closed his testimony echoing that sentiment. Mr. Thakur is a public health advocate and a former executive at Ranbaxy Laboratories in India.

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Schedule III Marijuana Would Still Be Regulated Marijuana

FDA Law Blog: Biosimilars

In January a public hearing began to receive factual evidence and testimony on whether marijuana should be rescheduled. DEA published a Notice of Proposed Rulemaking (NPRM), signed by Attorney General Merrick Garland, proposing to reschedule marijuana in May 2024 that elicited over 43,500 comments.

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Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution

Alta Sciences

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Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules

FDA Law Blog: Biosimilars

The purpose of the public hearing is to receive factual evidence and expert opinion testimony on whether marijuana should be rescheduled to schedule III. Parties will have ninety minutes to present the testimony of their witness. Prehearing Ruling (Dec. 4, 2024), at 1.