Newsletter | April 29, 2025

04.29.25 -- FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

FEATURED EDITORIAL

FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

INDUSTRY INSIGHTS

Leveraging Protein A Capture Technology, A Membrane-Based DSP

Learn how Sartobind Rapid A boosts mAb purification productivity 10-fold, supports membrane-based platforms, and enables intensified processes with improved yields, purity, and efficiency.

Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Development

Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.

Simultaneous Spray Drying For Large/Small Mol Combinations

Gain insights into a “simul-spray” process pioneering for combining small and large molecules into a single, atomized drug product for inhalation administration.

Implementing A Disaster Recovery Plan

When facing a malfunction, having an effective disaster recovery plan can make the difference between a swift fix, and losing your samples and time.

Binding Affinity Explained — Your Guide To Finding The Best Solution For Your Lab

Optimize lab purchases for binding affinity tools. Learn to measure, interpret, and apply binding affinity in biological research.

MOST POPULAR NEWS

Viatris Files sNDA To Japan's MHLW For The Approval Of EFFEXOR

TNF Pharmaceuticals And Renova Health Utilize AI To Accelerate Drug Development

CARBOGEN AMCIS Shanghai Site Awarded Drug Mfg License From Chinese NMPA

Argonne Leverages AI And Supercomputing To Revolutionize Cancer Research

Zai Lab Announces Acceptance Of sNDA For Repotrectinib

Charles River Leverages Advanced Technology To Expedite Oncology Drug Discovery

Redwire Expands In-Space Drug Development Program

UT Health San Antonio-Led Discovery Means IV Medication Could Be Taken Orally

CN Bio & Pharmaron Establish Long-Term Strategic Partnership

Galmed Pharmaceuticals Launches VCU Collaboration To Tackle Drug Resistance In GI Cancers

Kelun-Biotech's Novel ADC Drug SKB518 Has Been Granted The Clearance Of IND From The U.S. FDA

SOLUTIONS

Antibody Discovery & Engineering Services

Laboratory Services