News & Insights
Tips on Using ClinicalTrials.gov to Align Your Product Clinical Trial Designs with FDA expectations
One of the Clinical areas in which we at Biologics Consulting are asked to consult involves assisting a company that is planning clinical trials for their product and wishes to do so with minimal risk of failure. In the oncology clinical development space especially, the pace of change can result in…
COVID-19 Vaccine Cold Chain Management Compliance Considerations
With the advent of Coronavirus (COVID-19) disease as a public health emergency, and the development of novel vaccine candidates, addressing the challenges of cold chain management for storage and distribution will be critical. While vaccines typically require similar transport and storage controls, some…
Pre-IND Meeting Requests for COVID-19 Products
Given the numerous inquiries from prospective sponsors interested in conducting clinical trials for COVID-19 products, FDA has issued new guidance to assist sponsors in preparing Type B pre-investigational new drug application (pre-IND) meeting requests for COVID-19 related drugs and biologics1. This…
CGMP Compliance Challenges with COVID-19 Infection
With the advent of Coronavirus (COVID-19) disease as a public health emergency, FDA has issued new guidance on COVID-19 infection in employees [Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing/ Guidance for Industry…
FDA Postpones Foreign Inspections
As FDA is postponing most foreign inspections through April in response to the COVID-19 outbreak, there will undoubtedly be an impact on product application reviews and biennial GMP inspection approvals. During this time, FDA has committed to take interim measures that may include inspection waivers…