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BakerHostetler

FDA Issues Draft Guidance on Diversity Action Plans

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On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more

BakerHostetler

FDA Authorizes Florida’s Drug Importation Program

BakerHostetler on

On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...more

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Goodwin

Clinical Trial Diversity Plans and Rare Diseases

Goodwin on

Clinical trial diversity is not a new concept–the U.S. Food and Drug Administration (FDA) issued a draft guidance providing specific recommendations to industry on how to improve diversity in clinical trials in April 2022...more

Goodwin

Understanding Data Monitoring Committee Conflict of Interest Limitations

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For sponsors utilizing a data monitoring committee in their trial designs to monitor for emerging safety signals, lack of effect, and/or futility of treatment, understanding data monitoring committee conflict of interest...more

MoFo Life Sciences

Rare Disease: Sustained Progress In Development Regardless Of The Pandemic

MoFo Life Sciences on

Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In...more

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