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  • Regulatory NewsRegulatory News

    Senate Advances $1.1B in Emergency Zika Funds as House Fight Looms

    The Senate on Tuesday voted in favor of providing $1.1 billion in new funds to fight the Zika virus, which continues to spread in Central and South America and is expected to hit the US soon. The 68-29 vote in the Senate means the new funding could be added to an unrelated spending bill, though the funds are significantly less than the $1.9 billion President Barack Obama and the National Institutes of Health (NIH) requested three months ago to fight Zika. The Senate vot...
  • Regulatory NewsRegulatory News

    FDA Authorizes Use of Investigational Diagnostic to Screen Blood Donors for Zika

    The US Food and Drug Administration (FDA) on Wednesday said it will permit the use of an investigational blood test to screen donated blood for the Zika virus. In a statement, the agency said it is allowing the test, developed by Roche Diagnostics, to be used to screen blood in areas, such as Puerto Rico , where the virus is actively transmitted. When reached for comment, Roche spokesman Bob Purcell told Focus that screening with the test will begin "in the next few ...
  • Regulatory NewsRegulatory News

    FDA Sends Three Letters Over Unapproved Zika Diagnostics

    The US Food and Drug Administration (FDA) is taking steps to enforce its oversight of diagnostic tests used to detect the Zika virus, with three new letters to two laboratories and two Texas hospitals for marketing what it says are "high risk" unapproved diagnostics. The letters, sent to MD Biosciences, First Diagnostic Corp. and two Texas hospitals, Texas Children's and Houston Methodist Hospital, call on the recipients to contact the agency within seven days to discuss...
  • Regulatory NewsRegulatory News

    Genetically Engineered Mosquitoes to Aid Zika Response? FDA Plans to Release More Info

    The US Food and Drug Administration's (FDA) acting chief scientist told members of the House Energy and Commerce Committee on Wednesday that FDA is investigating all avenues to combat Zika, including a proposal to release genetically engineered mosquitoes in Florida. Scientists expect that the virus, which has swept across Latin America and the Caribbean, will eventually reach US shores, especially in states like Texas and Florida that have experienced outbreaks of dengu...
  • Regulatory NewsRegulatory News

    FDA Issues Guidance on Zika in Human Cell and Tissue Products

    The US Food and Drug Administration (FDA) on Tuesday announced new measures to prevent transmission of Zika virus via human cell and tissue products (HCT/Ps) by recommending a six-month deferral for at-risk donors. The virus, which has swept across Latin America and the Caribbean, is believed to be behind a spike in cases of microcephaly, a rare condition where an infant is born with an abnormally small head, and Guillain-Barré syndrome, a neurological disorder that can ...
  • Regulatory NewsRegulatory News

    Congress Considers Priority Review Vouchers for Medical Countermeasures

    Members of the House Energy and Commerce Oversight and Investigations subcommittee were briefed on recommendations at a hearing Friday for improving the nation's biodefence strategy against natural and man-made threats. The recommendations are particularly timely as legislators and public health officials scramble to mount a response to the Zika virus outbreak across Latin America and the Caribbean. Many of these recommendations come from the Blue Ribbon Study Panel on ...
  • Regulatory NewsRegulatory News

    CDC, NIH 'Working Closely' With FDA on Zika Response

    At a Congressional hearing in Washington, DC on Wednesday, officials from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) say they are working closely with the US Food and Drug Administration (FDA) in their response to the Zika virus. During the hearing, CDC Director Tom Frieden and Anthony Fauci, director of the National Institutes of Allergy and Infectious Disease (NIAID) briefed members of the House Foreign Affairs Committe...
  • Regulatory NewsRegulatory News

    US, EU & WHO Launch Efforts to Accelerate Zika R&D

    One week after the World Health Organization (WHO) declared a public health emergency in response to Zika-linked clusters of microcephaly, it and authorities in the US and EU are mobilizing to accelerate the development of treatments and diagnostics for the disease. Obama Calls for $1.8 Billion in Funding On Monday, the White House announced it will ask Congress for more than $1.8 billion to establish an emergency fund to combat the Zika virus in the US and abroad. N...
  • Regulatory NewsRegulatory News

    WHO Declares Public Health Emergency Over Microcephaly, Zika Suspected as Cause

    The World Health Organization (WHO) on Monday declared a public health emergency in response to clusters of microcephaly and Guillain-Barré Syndrome (GBS) in Brazil and French Polynesia suspected to be caused by the Zika virus. "I am now declaring that the recent clusters of microcephaly and other neurological abnormalities reported in Latin America, following a similar cluster reported in French Polynesia in 2014 constitutes a Public Health Emergency of International Co...
  • FDA Issues Revised Draft Guidance on Hepatitis C Drug Development

    The US federal government may have been shut down, but that didn't stop the US Food and Drug Administration (FDA) from releasing a new guidance document on 16 October 2013 detailing its preferred methods of developing applications in support of drugs to treat chronic infections caused by the hepatitis C virus. Background FDA has been rather active in the hepatitis C drug development space in recent years. In 2009, it issued a final guidance document, Guidance on Anti...
  • FDA Again Leverages Emergency Use Authority, Seeking to Stay Ahead of Deadly Mystery Virus

    For the second time in as many months, US regulators have leveraged new authority granted to them under recently-passed anti-bioterrorism legislation that allows them to approve products based on an understanding that an emerging virus could become a threat to public health. This time, however, the emerging virus is far different than the typical strains of influenza public health officials usually grapple with. Background In March 2013, the US Food and Drug Administrat...
  • EMA Releases Draft Guideline on Hepatitis B Vaccines

    The European Medicines Agency (EMA) has released a new guideline to instruct sponsors of clinical trials on best practices for assessing antibody-based products used to prevent the hepatitis B virus. The 2 December 2012 draft guideline, On the Clinical Investigation of Hepatitis B Immunoglobulins , is specifically aimed at vaccines, which EMA explains are an effective method for protecting uninfected, healthy individuals against infection by the hepatitis B virus. T...