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  • Regulatory NewsRegulatory News

    ACIP: First, vaccinate health care workers, nursing home residents

    In a 13-1 vote, the vaccines advisory committee of the Centers for Disease Control and Prevention (CDC) has voted to allocate the first rounds of COVID-19 vaccines to health care workers and residents of long-term care facilities.   “We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over finally,” said CDC’s Nancy Messonier, MD, director of the National Center for Immunization and Respiratory Disease...
  • Regulatory NewsRegulatory News

    FDA, CMS, CDC Launch Task Force for Emergency Diagnostics

    Three US Department of Health and Human Services agencies announced Tuesday the launch of the Tri-Agency Task Force for Emergency Diagnostics (TTFED) to better respond to public health emergencies. With the distinct roles set for each of the agencies, TTFED is intended to leverage the expertise of the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) around the development...
  • Regulatory NewsRegulatory News

    CDC National Stockpile of Medical Products Could be at Risk in Public Health Emergency

    The US Department of Health and Human Services’ Office of Inspector General (OIG) warns that "systemic issues" with the Centers for Disease Control and Prevention’s (CDC) stockpile of vaccines, antibiotics, antidotes, antitoxins, medications and other supplies could place at risk approximately $7 billion of inventory and negatively affect readiness during a national emergency. Background Created in 1999, the stockpile is meant to supplement and resupply state and...
  • New Study Says 63% of US Adults Trust FDA

    A study published Tuesday in PLOS reveals that the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) might have more work to do to ensure Americans trust them. In a study of more than 5,000 adults and 1,100 adolescents, the researchers from the University of North Carolina found that among adults, awareness of CDC and FDA was high (83.6% and 94.3%, respectively) but adults’ trust in the agencies was lower, with 64.6% reported...
  • Regulatory NewsRegulatory News

    FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak

    An investigation into a multistate outbreak has identified the bacteria, Burkholderia cepacia , in more than 10 lots of oral liquid docusate sodium linked directly to a contract manufacturing organization’s (CMO) Florida-based site.   PharmaTech in August voluntarily recalled all of its liquid drug formulations made at the Davie, Florida facility after being linked to the outbreak. The recall impacted products distributed and labeled by six firms – Rug...
  • 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 Clears First Zika Diagnostic for Emergency Use

    The US Food and Drug Administration (FDA) on Friday approved the first diagnostic to detect the Zika virus under its emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved products during a public health emergency. The authorization is significant as there are currently no other approved diagnostics available to detect Zika, a mosquito-borne virus that has rapidly spread across much of Latin America and the Caribbean and is thought to ...
  • Regulatory NewsRegulatory News

    WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries

    A World Health Organization (WHO) pilot project looking to bring already-approved drugs to Africa more quickly will continue into 2016 after four of 11 participating African national medicines regulatory authorities (NMRAs) approved Janssen’s pediatric HIV drug Intellence (etravirine). As of November, regulators from Namibia (approved 86 days after submission), Cote d’Ivoire (four months), Botswana (six months) and Kenya (seven months) have approved the use of the drug, ...
  • 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

    African Union, WHO Team Up to Launch African CDC

    Officials at the African Union Commission (AUC) and the World Health Organization Regional Office for Africa (WHO/AFRO) are looking to address the shortcomings of the international response to the Ebola crisis by launching a new disease monitoring agency, the Centres for Disease Control and Prevention in Africa (African CDC). Background Africa has the world's highest burden of disease , with far higher mortality rates for infectious diseases than any other region. Many...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • Regulatory NewsRegulatory News

    FDA, CDC Preparing Updated Form to Record Vaccination Problems

    The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form. Background In a notice published in the Federal Register on 24 November 2014, CDC said it's accepting public input on its proposed Vaccine Adverse Event Reporting System (VAERS) 2.0 form. VAERS is used by FDA and CDC, which co-administer th...