Pharma
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FDA seeks comments on expedited CNPV pilot program
The controversial Commissioner’s National Priorities Voucher program awards “ultra-fast” reviews for medications and biological products of strategic national importance while upholding the FDA’s standards.
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Badly fitting risk – lessons from impact investment
When buying off-the-shelf guff policies leads to poor risk management: what to look out for and what to avoid.
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Pfizer receives PMCPA censure for providing business-class flights to UK HCPs
Ruling reinforces long‑standing Code of Practice expectations on appropriate hospitality, certification, and standards across the pharmaceutical industry.
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FDA to streamline biosimilar development to lower drug prices
New federal guidance recommends using drugs approved outside of the US as comparators to cut down on pricey pharmacokinetic testing.
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FDA issues warnings to 30 telehealth companies over marketing violations
The letters warning of false or misleading marketing claims point to a transition from the agency’s traditional complaint-driven oversight to a more proactive monitoring system.
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Changing UK product liability law: potential effects on the healthcare sector
Proactive steps companies in the healthcare sector (or those that insure or invest in those businesses) should take now.
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Global pharmaceutical syndicate dismantled
The sheer scale of the operation highlights the borderless nature of health-related financial crime.
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FDA announces new regulatory framework for ultra-rare disease therapies
The guidance will enable the agency to accelerate approval on new treatments for diseases affecting fewer than 1 in 50,000 people.