Fox Rothschild's Mark Wagner on why drug shortages are so hard to fix — from the definition gap to API dependency to three-year site approvals.
Marc Wagner
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Marc Wagner is an FDA and life sciences attorney at Fox Rothchild.
Articles by Marc Wagner
Fox Rothschild's Marc Wagner on why domestic manufacturing reduces drug shortage risk — and why FDA inspection efficiency is as important as supply chain resilience.
Fox Rothschild's Marc Wagner on how 503A pharmacies and 503B outsourcing facilities fill drug supply gaps — from COVID injectables to GLP-1s.
Fox Rothschild's Marc Wagner on why scaling drug production is so slow — overseas API sourcing, supplier qualification, and FDA site approvals that take years.
Fox Rothschild's Marc Wagner on why the FDA counts 70 drugs in shortage while ASHP counts 188 — and what's driving the gap.
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