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

 
  • Regulatory NewsRegulatory News

    FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients

    The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients. DGF is a condition that involves suboptimal kidney function immediately following a kidney transplantation, and is usually defined as the need for dialysis within seven days of receiving a transplant, though FDA notes there are other accepted definitions for the condition. Ther...
  • Regulatory NewsRegulatory News

    FDA Finalizes Policy to Cut Down on Suspicious Behavior During Facility Inspections

    The US Food and Drug Administration (FDA) has put the finishing touches on a new policy intended to ensure the companies it regulates aren't able to hide problems from it during the course of inspections. Background In July 2013, FDA released a draft guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection seeking to clarify its newfound authority under the Food and Drug Administration Safety and Innovation Act (FD...
  • Regulatory NewsRegulatory News

    FDA Flexes New Inspection Authority, Banning Company After it Refuses to be Inspected

    The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators. The company, Beijing Shunxin Meihua Bio-technical Co., was placed on import alert by FDA on 22 July 2014. FDA's import alerts—one for refusing inspection , and the other for failing to operate according to good manufacturing practi...
  • CMS Announces Planned Data Collection Under Sunshine Act Delayed Until 2013

    • 08 May 2012
    The US Centers for Medicare and Medicaid Services (CMS) announced 3 May it would postpone a planned data collection mandated by the Physician Payments Sunshine Act (PPSA) , saying it would not collect any information until 1 January 2013. CMS's 19 December 2011 proposed rule on Section 6002 or PPSA stipulated the agency would begin collecting data from manufacturers this year covering their payments, gifts and other forms of compensation given to physicians. The age...