• 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    The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients.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...
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    FDA Looking for Two New Cellular and Gene Therapy Fellows

    • 28 March 2016
    The US Food and Drug Administration’s Division of Cellular and Gene Therapies is opening up two contract fellowship positions: one to study the potential of human pluripotent stem cells for developing gene and cell therapies, and one to further investigate mechanisms that RNA viruses use to inhibit host immune cell function. Candidates with research experience in virology, immunology, cell biology, molecular biology or gene therapy will receive the strongest consideratio...
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    CBER Calls on HCT&#47P Manufacturers to Report Adverse Events Within 15 Days

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Tuesday issued new guidance to provide establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable diseases. CBER notes that examples of HCT/Ps that are subject to adverse reaction reporting and fall with...
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    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 Background In July 2013, FDA released a draft guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection seeking to clarify its newfound authority under the Food and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...
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    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...
  • Separate OIG Reports Uncover Systemic Problems With Regulation of Supplement Industry

    Two new reports released by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) call for additional oversight over the dietary supplement industry, with government investigators chiding the industry for routinely flouting federal requirements and being difficult to track . That supplement companies routinely run afoul of US Food and Drug Administration (FDA) regulation should be of no surprise to its regulators. Its officials, ...
  • 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...