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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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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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R&D Partnering Testimonials from Bayer, Oldcastle and Joyn Bio

Translation

The company received proposals from over fifty institutions, including 40 universities and 10 government labs, surfacing licensing candidates from diverse partners. The post R&D Partnering Testimonials from Bayer, Oldcastle and Joyn Bio appeared first on Translation | Halo Blog.

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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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WHO and Key Stakeholders Launch Disability Health Equity Partnership

The Pharma Data

The announcement was made during the 18th session of the Conference of States Parties to the Convention on the Rights of Persons with Disabilities (CRPD) —an event that drew over 150 in-person participants from government, civil society, academia, and the disability community, with many more attending virtually.

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Bayer announces filing of petition to U.S. Supreme Court for review of Hardeman decision

The Pharma Data

Government argued in its amicus filing in the Ninth Circuit. Second, the admission of expert testimony departed from federal standards, enabling plaintiff’s causation witnesses to provide unsupported testimony on the principal issue in the case, Roundup ’s safety profile.

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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.