Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
Jean-Noel David, Managing Director at Seqens CDMO NA, identifies six key trends that promise to reshape the pharma landscape during 2021 and beyond.
If organizations want to maintain a trustworthy image and connect with their customers, transparency in the pharmaceutical industry needs to become a higher priority. One way to address this situation is to highlight the commitment to ingredient traceability.
Thermo Fisher Scientific is significantly expanding the company’s footprint with new facilities in the United States and in Europe.
A U.S. FDA investigator discovered that India’s Strides Pharma Science Ltd. – which exports to the U.S. market – was shredding drug production, quality and laboratory documents.
A federal judge ordered Florida-based Stratus Pharmaceuticals and New Jersey-based Sonar Products to cease the manufacturing and distribution of drugs that are unapproved, mislabeled or contaminated.
The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
A Complete Response Letter was issued by the U.S. FDA regarding the BLA for sarilumab, a rheumatoid arthritis drug being co-developed by Regeneron and Sanofi.
Heart device maker St. Jude Medical Inc received a warning letter from the U.S. Food and Drug Administration, which said that various devices of the company manufactured at its Atlanta plant are adulterated. The health regulator in a letter dated Sept. 30 also warned that the company’s manufacturing, packing, storage and installation practices “are not […]