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  • Facing Criticism, FDA Rethinking Some Therapeutic Equivalence Standards

    US regulators are taking a second look at the way generic drug applications for extended-release generic drug obtain approval several weeks after finding that Teva Pharmaceuticals and Impax Laboratories' Budeprion XL 300mg, supposedly generic to GlaxoSmithKlines' Wellbutrin 300mg, was in fact not therapeutically equivalent. The finding was a setback for the US Food and Drug Administration (FDA), which has fastidiously maintained that nearly all drugs approved through i...
  • Woodcock Proposes Creation of Generics Super Office, New Office of Drug Quality

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is preparing for the likely elevation of the Office of Generic Drugs (OGD) to a new 'Super Office' in which a number of other CDER offices would be contained. "I am proposing to elevate the Office of Generic Drugs (OGD) to a 'Super Office,'" wrote Janet Woodcock, director of CDER, in an email to FDA staff on 7 September. "As a 'Super Office,' OGD would report directly to me, as do ...
  • Office of Generic Drugs Receives New Director

    The US Food and Drug Administration (FDA) announced 14 June the hiring of Greg Geba, MD, MPH as the new Director of the Office of Generic Drugs (OGD). Geba is a 15-year veteran of industry, having served most recently as the Deputy Chief Medical Officer for Sanofi US. In an email sent to internal FDA staff, the Office of Pharmaceutical Science (OPS) said it was particularly pleased with Geba's track record of "more than 20 currently marketed drugs or devices across mul...