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Research and Development Patient Access

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

Troutman Pepper Locke on

Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim...

Maynard Nexsen on

Recorded at SCBIO’s 2024 annual meeting, hosts Heather and Lauren welcome healthcare economist and GlobalData Director Tim Dall, who has studied the economic burden of chronic disease for over 25 years. The group discusses...more

Nelson Mullins Riley & Scarborough LLP

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more

Hogan Lovells

The Belgian AFMPS warns about risk of hemolysis associated with the use of hydroxychloroquine

Hogan Lovells on

On 14 April 2020, the Belgian Federal Agency for Medicines and Health Products (AFMPS), published a news flash warning physicians of the risk of hemolysis associated with the use of hydroxychloroquine in patients with...more

Hogan Lovells

FDA Simplifies and Clarifies Expanded Access Program

Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

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