FDA Pharmaceutical Quality ‘Super Office’ Launches With Integrated Reviews
This article was originally published in The Tan Sheet
CDER’s ‘super office’ aims to transform how industry thinks about manufacturing, but still needs to hire management and other staff.
You may also be interested in...
FDA’s drug center continues to operate with a staffing shortage at a time of tremendous pressure to implement new authorities. Janet Woodcock is left scrambling to find senior managers to lead top initiatives. Direct hiring authority has helped but doesn’t fully address FDA’s recruiting challenges: too much red tape and too little money.
It took a while, but the Office of Pharmaceutical Quality is finally ready to begin operations. Biopharma companies should recognize the declaration of FDA’s priorities, and respond accordingly.
The Office of Generic Drugs may evolve to focus more on clinical issues as the new Office of Pharmaceutical Quality creates uniform standards for manufacturing process engineering and other production areas, the CDER director says in an interview.