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  • Marshals Seize Unapproved Drugs from Manufacturer After Purported INDA Violations

    The US Marshals service, at the direction of the US Food and Drug Administration, moved on 22 May to seize stock of an unapproved drug product from pharmaceutical manufacturer Crescendo Therapeutics after the company allegedly continued to flaunt federal regulations. FDA said Crescendo's HybriSil product, a methylprednisolone aceteate suspended in silicone gel, was being marketed as a prescription topical corticosteroid in various venues. The agency had inspected Crescen...
  • Bill Introduced to Speed Development and Review of Breakthrough Therapies

    A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies , would amend the FD&C Act  to include pr...