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  • Regulatory NewsRegulatory News

    Should FDA Make Changes to the Way it Regulates Homeopathic Products? Agency Wants to Know

    The US Food and Drug Administration (FDA) regulates many types of products—drugs, medical devices, cosmetics, food, lasers and tobacco among them. But you'd be forgiven if you forgot the agency regulates another type of medicine: homeopathy. Now FDA wants to know if its regulatory framework for regulating homeopathic products is adequate, and whether changes are needed. Background When you think of the term "drug," you most likely think of traditional pharmaceutical pr...
  • FDA Hits Two Compounders for Making J&J Drug That Lacked US Approval

    Two compounding pharmacies are the latest recipients of Warning Letters from the US Food and Drug Administration (FDA), part of a recent surge of letters reflecting the agency's new authority under the Drug Quality and Security Act (DQSA) . Background: Compounding Pharmacies and the DQSA Unlike more traditional pharmaceutical manufacturers-think Pfizer, for example-compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose o...
  • New Compliance Guide Calls on Veterinary Food Manufacturers to Adhere to Good Practices

    The US Food and Drug Administration (FDA) has announced the release of a new draft compliance policy guide (CPG) regarding the labeling and marketing of veterinary food products intended for use in canine and feline species. The CPG is intended to broadcast the agency's anticipated use of its enforcement discretion for products that are specifically intended to diagnose, treat, cure or prevent disease in the two species. FDA said its Center for Veterinary Medicine (CVM) ...
  • FDA: Blood Products Policy Guide 'Obsolete'

    The US Food and Drug Administration (FDA) has withdrawn its compliance policy guide (CPG) governing the registration of blood banks and other companies  that prepare human blood and blood products-the third such withdrawal made this week. In a Federal Register notice posted late on 26 June, FDA said it believes its 1974 CPG, Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products (CPG 7134.01) , ...