FDA Study Finds Geography Not A Good Predictor Of Quality for Hard-To- Make Drugs
Executive Summary
An FDA study asserts that where a drug is made is not necessarily a good indicator of its quality, and that for some hard-to-make drugs, the same manufacturing problems affect drugs in the US as in other parts of the world.
You may also be interested in...
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.
US FDA Mulls Advance Notice On Domestic Surveillance Inspections Post-COVID
Criticized for giving foreign sites advance notice of inspections, agency is considering giving such notice to domestic sites too even after surprise inspections become possible.