RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • FDA Marks Half-Century of Regulation Based on Safety, Efficacy

    A half-century ago today, the US Food and Drug Administration (FDA) experienced perhaps its greatest expansion of regulatory authority since its inception, allowing it to regulate pharmaceutical products based not only on the safety of a product but their efficacy as well. That authority, granted by the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act of 1938, came in the wake of an international regulatory crisis involving Thalidomide, a drug in...
  • Two Receive Debarments for FDCA Violations

    Two doctors are on the receiving end of debarment orders issued by the US Food and Drug Administration (FDA) after the agency found both to have injected patients with an unapproved and illegally obtained version of Botox (botulinum toxin) in violation of the Federal Food, Drug and Cosmetic Act (FDCA) . The two had separately obtained illicit versions of Botox-commonly used as a cosmetic agent to reduce wrinkles-from Toxin Research International, Inc (TRI). The first, ...
  • Cosmetic Regulation Under Review in Congress

    The House Energy and Commerce Committee is slated to review the safety and regulation of cosmetics in a hearing scheduled for 27 March. The hearing intends to explore the possibility of establishing national standards for cosmetic ingredients, which the Committee writes "would serve to further public health by ensuring these decisions are made using sound science and ensure that the interstate flow of cosmetic products is not disrupted by differing State standards." "U...
  • FDA Releases PMA Summaries for Q4 2011

    The US Food and Drug Administration (FDA) is updating its list of available safety and effectiveness summaries of Premarket Approvals (PMAs) to include all decisions made in the fourth quarter of 2011. The updated list includes the PMA docket number, applicant, trade name of the product and the product's approval date, as well as the complete safety and effectiveness summary by FDA. All 15 products added to the list during the 4 th quarter of 2011 were approved. Under...