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June 13, 2024
Key information is needed for excipients and their potential impact on continuous manufacturing processes.
June 11, 2024
A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.
June 10, 2024
The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.
USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.
June 08, 2024
The final drug product relies on the quality and reliability of the raw materials used in its production.
June 07, 2024
Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.
June 05, 2024
EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.
June 04, 2024
CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.
May 30, 2024
A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
FDA granted priority review to Sanofi's sBLA for Sarclisa in combination with VRd in treating transplant-ineligible patients who are newly diagnosed with multiple myeloma.