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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. These documents provide recommendations and considerations for clinical pharmacology , nonclinical safety assessments, and bioanalytical method validation. Tags Bioanalysis Regulatory Affairs Weight 15

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Top 10 Life Science Resources for Summer 2024

Alta Sciences

Top 10 Life Science Resources for Summer 2024 pmjackson Thu, 07/25/2024 - 14:44 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

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Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

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Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. fit in this definition.

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How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.