The US Food and Drug Administration has approved more than a dozen product submissions using alternative tools in place of site inspections that would normally be a condition of approval but are difficult or impossible to conduct during the COVID-19 pandemic.
How The US FDA Finds Pre-Approval Inspection Alternatives During COVID-19 Pandemic
Officials explain how remote record reviews, site transfers and other factors can green-light approvals of drugs and biologics.
More from Manufacturing
More from Compliance
• By
Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
• By
Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
• By
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.