Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable
Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.
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Selective whistleblower allegations, investigative reports hint at drug GMP issues awaiting US FDA inspection resumption; GSK sotrovimab EUA gets root cause provision; API GMP compliance work acknowledged; Aziyo recalls bone matrix associated with tuberculosis outbreak, and other matters in this latest update.
‘Wartime’ contract with BARDA will fund up to $268.8m in production site upgrades so Merck can also produce other COVID-19 vaccines and therapeutics as needed.
Tipped off by whistleblower, Fresenius reviewed data integrity audits that led it to back away from plans to acquire Akorn, firm tells court. It’s a case with lessons for any pharmaceutical company that wants to ensure its own data integrity – and that of its business partners.