September 2nd 2024
Updating your audits and inspections program ensures inspection preparedness, says Siegfried Schmitt, vice president, Technical at Parexel.
Investigation Timeliness vs. Thoroughness: Finding the Right Balance
December 1st 2018A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.
US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting
June 22nd 2018FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.
FDA Commissioner Outlines New Step for Stronger Drug Manufacturing Oversight
September 1st 2017A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.