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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. If you choose to forgo a hearing, the government will forward your case with its evidence (along with any timely submitted position statement) to the Administrator.

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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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Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. What is a government shut down? If none of the 12 bills are completed, then all government operations shut down.

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GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Law Blog: Biosimilars

In 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program. That report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. But gaps still remain.

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

Agency IQ

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. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

What about government factors that cause drug shortages? What the White Paper does not adequately address is whether there are any government-controlled factors that also cause drug shortages. For example, how would HRSP incentives/penalties apply to low-cost, high-volume medical devices (e.g., surgical robots, MRIs)? Section I.C

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