August 28th 2025
The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.
FTC Finds 60% Increase in Pay-to-Delay Deals
May 12th 2011In fiscal year 2010, the number of patent settlements in which the manufacturers of branded products paid makers of generic drugs to postpone the introduction of their products reached its highest level ever, according to the Federal Trade Commission.
Industrializing Design, Development, and Manufacturing of Therapeutic Proteins
May 1st 2011The authors discuss various approaches and related issues, including production of difficult-to express proteins using cell-free expression systems, scalability of protein expression, and site-specific chemical modifications.