A Rapid, Cost-Effective Option for Electronic (eCTD) Submissions - Beckloff Whitepaper

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

The company estimated that more than 1000 women in Scotland at very high risk of fracture would be eligible for treatment.