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Latest From Bowman Cox
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.
It may have seemed like a ‘no brainer’ for FDA to immediately remove the outdated two-year inspection requirement for biologics facilities, but the agency will trudge through the full rulemaking process instead owing to what it called ‘significant adverse comment.’ Such a slow turning of bureaucratic gears might not bode well for the Trump administration’s regulatory reforms.
CMC Regulatory Updates In Brief: Complete Response Tallies And Guidance On Inhalers, Supplements, Liposomes And H2O2
US FDA attributes 12% of last year's complete responses to manufacturing facility issues. Separately, it proposes a major revision of its 1998 draft guidance on drug quality for metered dose and dry powder inhalers, revises 1999 internal guidance on CMC supplements, and finalizes guidance on CMC considerations for liposomes drafted in 2015, while UK MHRA cautions firms against relying on VHP to sterilize isolator parts.
As market forces, seasonal flu and extreme weather cause US shortages of intravenous saline solutions to persist, providers writing in NEJM are heartened by idea that federal Homeland Security Department could step in to require manufacturing redundancies. Will industry solve the problem before it becomes a matter of national security?
US FDA would gain more of the ability it seeks to interdict illicit opioids at the border under legislation proposed by House Energy & Commerce Committee's top Democrat. But would there be collateral damage to the legitimate pharmaceutical industry?
US agency's Office of Pharmaceutical Quality continues to accelerate review and inspection processes, according to its first annual report. Meanwhile, the office's signature quality metrics initiative goes underground.