Join Lead Quality Systems and Compliance Consultant Steven Niedelman for a comprehensive webinar on what to expect during an inspection as well as the “Do’s and Don’ts” during an inspection.
This week, FDA issued 42 warning letters to firms and individuals who distribute unapproved new drugs to prevent or treat COVID-19 infections, as well as two untitled letters and five warning letters to pharma/device firms.
Avoiding and Reacting to Human Tissue, Cell and Gene Therapy Enforcement Actions: Communication is Key
“The beauty of the TRIP program,” Laney said, “is that it is informal and non-binding. It is an open forum for tissue manufacturers and processors to talk to the agency and get advice in a way that fuels open communication on a rapid-response timeline.”
No warning letters to drug firms were posted this week. One warning letter was issued to a device firm and one untitled letter was issued to a stem cell firm.
This report presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
Human Cell and Tissue Therapy Enforcement Actions Target Unapproved New Products Making Unsubstantiated Claims
While some companies are submitting applications to CBER seeking agency approval for marketing HCT/Ps, others are marketing and administering products they claim will treat various diseases and conditions without proof of the claims and without agency approval.
Among the areas we cover, FDA posted one warning letter issued to a fertility clinic governed by the HCT/P regulations and one to a compounding pharmacy.
Join Technical Operations Manager Ernest Blanchard for a comprehensive webinar about the concept of risk management and risk-based thinking within management systems for GxP professionals.