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  • Regulatory NewsRegulatory News

    With $5 Million Grant, FDA Wants to Change how the US Responds to Future Public Health Emergencies

    A new $4.9 million contract awarded by the US Food and Drug Administration (FDA) seeks to improve how the agency deploys medical countermeasures during public health crises like Ebola. Background "In emergency situations, rapid response is critical," FDA writes on its website. And while that response often includes basic provisions—money to buy supplies and the deployment of healthcare providers to an area, for example—it almost always includes medical products like dru...
  • Regulatory NewsRegulatory News

    FDA Facility Held Unknown Vials of Smallpox, Dengue, Q Fever and Other Deadly Diseases

    The US Food and Drug Administration (FDA), just days after announcing that it had found decades-old vials of variola —the virus which causes smallpox—inside a storage facility it owned, has announced that the deadly virus wasn't the only dangerous substance it found during a cleanout of the facility last month. Dangerous Substances In a statement released to the press on 16 July 2014, the agency confirmed that it found hundreds—327 to be exact— of "carefully packaged v...
  • Regulatory NewsRegulatory News

    FDA Chides GSK Subsidiary for Flu Vaccine Manufacturing Troubles

    A Canadian subsidiary of pharmaceutical company GlaxoSmithKline (GSK) has been accused by the US Food and Drug Administration (FDA) of deviating from good manufacturing practice (GMP) regulations while manufacturing the flu vaccine FluLaval . The allegations, contained in a Warning Letter released by FDA on 24 June 2014, stem from a 31 March-9 April 2014 inspection of ID Biomedical Corporation's—a GSK subsidiary since 2005—Quebec facility. The bulk of the allegati...
  • Regulatory NewsRegulatory News

    FDA Proposes Strengthening Requirements for Rapid Flu Tests

    US Food and Drug Administration (FDA) regulators are proposing to reclassify some Influenza Antigen Detection Test Systems into a higher-risk category than the systems now inhabit, citing potential for the devices to fail to detect newer versions of the virus. Background The devices, which are used to detect the presence of influenza in a clinical sample, were Classified as low-risk Class I medical devices in 1982. Class I devices only require the company to adhere to g...
  • Diploma Mill Peddled Homeopathy Product as Flu Prevention Method, FDA Claims

    US regulators frequently send warning letters to all sorts of companies for alleged violations and deficiencies; everyone from drug and device manufacturers, to institutional review boards, to small supplement manufacturers. But rarely, as the US Food and Drug Administration (FDA) did last week, do they send one regarding homeopathy products or to an online diploma mill-an unusual combination if there ever was one. Background Homeopathic products are usually just wate...
  • Rare Multi-Agency Warning Letter Slams Flu Product

    The US Food and Drug Administration (FDA) has issued a rare multi-agency warning letter to a marketer of a product claiming to give patients protection against the influenza virus. The letter, sent on 24 January 2013 to Flu and Cold Defense LLC ('FCD'), was sent in conjunction with the Federal Trade Commission (FTC). Both FDA and FTC regularly work together on matters related to advertising, but the joint warning letter is extraordinarily rare, as FTC ordinarily defers...
  • FDA Approves New Flu Vaccine with Potential Biodefense Applications

    The US Food and Drug Administration (FDA) has announced the approval of a new type of flu vaccine that provides an alternate option to those unable to consume egg-based products. The new vaccine, Flublok, is a trivalent influenza vaccine manufactured by Meriden, CT-based Protein Sciences Corporation. Unlike other flu vaccines, which utilize a live virus to infect chicken eggs, Flublok is made from only a single hemagglutinin protein from the influenza virus. That prote...
  • Italian, Swiss, Spanish Regulators Ban Sale of Novartis Flu Vaccines

    • 26 October 2012
    • By
    Two influenza vaccines manufactured by Novartis, a Swiss pharmaceutical company, have seen their marketing privileges temporarily revoked in at least three European countries this week as regulators expressed concerns regarding contamination and possible adverse side effects. The vaccines-Agrippal and Flaud-were first banned by the Italian Health Ministry after the Italian Pharmaceutical Agency (AIFA) said it was aware of the, "Presence of a protein aggregation phenome...
  • FDA Releases Guidance on Reporting Adverse Events During Flu Pandemic

    The US Food and Drug Administration (FDA) released a final guidance on 24 February that deals with how it intends to enforce adverse event reporting (AER) requirements if-or when-an influenza pandemic occurs. FDA notes that during a pandemic  it anticipates that its resources-and those of some manufactures-will be deployed most prominently to deal with that particular public health issue. This is problematic, as the amount of products being used to combat influen...