Pharma’s Bedtime Horror Stories: Gene Therapy, Digital Revolution, Pricing ‘Fixes’
Regulators, industry executives, and patient advocates are losing sleep due to a host of concerns and anxieties, including the need for evolving regulatory paradigms, patients’ ability to access life-changing medicines, and the pace of digital change.
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Measure clarifies the meaning of new chemical entity by replacing the term ‘active ingredient,’ which encompasses esters and salts, with ‘active moiety’ as defined by the FDA; legal experts are skeptical the measure will generate cost savings and say it gives the agency wide latitude to make future changes in eligibility for 5-year exclusivity.
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