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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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What To Do When You Receive a DEA Order to Show Cause

FDA Law Blog: Biosimilars

Both the government (represented by DEA counsel) and you will have an opportunity to present your case through witness testimony and record evidence. DEAs Office of Administrative Law Judges has a website containing forms and links to a variety of helpful legal resources, including instructions on filing documents.

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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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New FDA guidance on addressing misinformation under White House review

Agency IQ

BY LAURA DIANGELO, MPH A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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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.

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Analysis Chemical Thank You Freedhoff testifies in front of Senate EPW over TSCA implementation

Agency IQ

SHELLEY MOORE CAPITO (R-WV) opened the testimony. Capito noted that she had shared a document with Freedhoff earlier in the week that included some potential options to improve the pace of new chemical review. Key Documents and Dates Hearing page Freedhoff Testimony (January 4, 2024) Opening Sen.

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Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Agency IQ

We’ve also included documents that are actively under White House review – a process which often takes several weeks (or months) to conclude. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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