March 14th 2025
The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
Merck & Co.’s Application for Ebola Vaccine Accepted by FDA and Granted Priority Review
September 19th 2019In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.
Pharmacopoeia Compliance Series
September 18th 2019In this series of articles, J. Mark Wiggins, owner and compendial consultant with Global Pharmacopoeia Solutions LLC, and Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC, provide an understanding about the need for pharmacopoeia compliance.
Risk-Based Intermediate Precision Studies for Analytical Procedure Validation
September 15th 2019Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
California Company, Stemell, Receives Warning Letter
September 6th 2019FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.
Federal Court Enters into Consent Decree with Tennessee Distributors
September 6th 2019A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.