Joanne S. Eglovitch
Senior Editor
Latest From Joanne S. Eglovitch
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.
US FDA Mulls Possibility Of Preannouncing Post-COVID Domestic Surveillance Inspections
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.
FDA Relying More On Predictive Analytics To Help Monitor Quality Risks Of Sites During Pandemic
Analytics tool plays key role in helping agency oversee quality of 1,800 newly registered hand sanitizer facilities despite travel restrictions.
Legislators Clamor For More Surprise FDA Inspections Abroad
House lawmakers who get the first cut at setting the FDA’s budget joined GAO expert in raising concerns about shortage of investigators and lack of surprise for foreign inspections.