FDA Center for Drug Evaluation and Research (CDER) microbiology reviewers are assuring companies that they will be supportive of efforts to upgrade lab methods and manufacturing processes to take advantage of post-approval scientific advancements.
Agency support for these upgrades was affirmed by CDER Product Quality Microbiology Reviewer Jessica Cole at the PDA Aseptic Processing/Sterilization Conference in mid-June in Chicago.
In the first part of her presentation, Cole provided an overview of how the New Drug Microbiology Staff (NDMS) works and what they look for in drug applications, and reviewed the “top 10” problem areas in micro submissions (IPQ July 21, 2014).
She went on to discuss FDA’s receptivity to new micro analytical technology – commenting on why industry fears may be unfounded and providing case studies of how new technologies were approved. She also offered advice on expediting the clearance process.