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

FDA Law Blog: Biosimilars

We’ve blogged previously on the troubles FDA has faced ramping up its foreign inspections program after the pandemic. 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.

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

Translation

The post R&D Partnering Testimonials from Bayer, Oldcastle and Joyn Bio appeared first on Translation | Halo Blog.

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

FDA Law Blog: Biosimilars

Many have noted that FDA has been slow to recover We’ve blogged before on FDA’s post-pandemic inspection work, writing about the resumption of both good manufacturing practice (GMP) and bioresearch monitoring (BIMO) inspections. Inspections went down—way down—during the pandemic.

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Celebrating Diversity, Inclusion, and Belonging

Perficient: Drug Development

Encourage colleagues to write blogs on Cultural Connections removes unconscious Reinforces diversity and inclusion ​. This blog post is a celebration of Perficient’s culture and its promise to championing diversity and inclusion. Plan activities and events around culture that aids in creating a sense of belonging ​.

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React v19: A Game-Changer for React Developers !

Perficient: Drug Development

In this blog, well explore the most impactful features of React 19 with examples to understand how they change, the way we build React applications. If CourseWrapper takes longer to receive its data, CourseList and Testimonials cannot render until CourseWrapper completes. Key Features of React 19 1.

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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Conversations in Drug Development Trends

These meetings are designed for attendees to hear testimonies from clinicians, patients, caregivers, and families about the issues facing these stakeholder groups in the diagnosis, treatment, and long-term prognosis of a disease as it is experienced in real life – not through an impersonal, peer-reviewed case report.