Joanne S. Eglovitch
Latest From Joanne S. Eglovitch
The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.
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.
Pharmaceutical manufacturers should have already begun serializing products and verifying saleable returns to comply with DSCSA, says FDA official who also asserted that licensing standards for wholesale distributors and third-party logistics providers will be forthcoming. This rule is already six years overdue under a DSCSA mandated timeline.
The US FDA wants manufacturers and compounding facilities to test drug products for methanol in alcohol ingredients, and responds to reports of fatal methanol poisonings of consumers who ingested alcohol-based based hand sanitizers.
While COVID-19 continues to wreak havoc on FDA's ability to perform onsite preapproval inspections, new guidance offers some clarity, but the news isn't great for ANDA holders.