US FDA Relaxes Vigilance On Sample Retains For Bioavailability, Bioequivalence Testing
The US FDA will allow fewer reserve samples to be set aside for BA and BE testing due to test method improvements.
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The appropriate number of reserve samples from studies supporting an ANDA should be at least 300 units as a default, FDA said
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.