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  • Regulatory NewsRegulatory News

    HHS seeks drug importation waiver applicants

    The US Department of Health and Human Services (HHS) has issued a request for proposals (RFP) from individuals who wish to seek waivers permitting them to import prescription drugs from certain countries.   The RFP, issued 24 September 2020, provides a pathway for individuals who have waivers to import some FDA-approved drugs through authorized state-licensed pharmacies. Countries considered an “acceptable foreign source” by HHS for the purposes of the waiver include A...
  • Regulatory NewsRegulatory News

    Former commissioners call on administration to end FDA criticism

    Seven former commissioners of the US Food and Drug Administration (FDA) came together to call out the Trump administration for undercutting FDA’s credibility as the agency prepares to evaluate clinical trial data for vaccines against SARS-CoV-2, the virus causing the novel coronavirus pandemic.   Their comments, made in an opinion column published 29 September in The Washington Post , were welcomed by the FDA’s current vaccines chief, Peter Marks , MD, PhD, directo...
  • Regulatory NewsRegulatory News

    FDA warns of infection risk with CardioQuip heater-cooler

    The US Food and Drug Administration (FDA) on Wednesday warned health care providers about the potential risk of Mycobacterium abscessus , a type of nontuberculosis mycobacteria (NTM), infection during cardiac surgery when using CardioQuip’s Modular Cooler-Heater.   The warning is the latest in a series of safety communications and other regulatory actions related to heater-cooler devices since 2015 , when FDA first raised awareness of the risk of NTM infection post...
  • RoundupsRoundups

    FDA Approvals Roundup: Nucala, Fetroja, Xeljanz

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Nucala gets expanded indication for HES GlaxoSmithKline’s Nucala (mepolizumab injection) has been granted a new indication for the treatment of hypereosinophilic syndrome (HES) in adults and children 12 years and older. The indication is for patients who have had HES for six months or longer, with no other identifiable nonblood-related cause o...
  • Regulatory NewsRegulatory News

    Hahn insists FDA will stick to guidelines for COVID-19 vaccine decisions

    Speaking at the Financial Times ’ US Pharma and Biotech Summit on Tuesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said the agency will stick to the standards and criteria it has laid out to approve or authorize applications for vaccines to prevent coronavirus disease (COVID-19).   In recent weeks, Hahn has made numerous statements asserting that the agency will not approve or authorize a vaccine that does not meet the agency’s “rigorous expect...
  • Regulatory NewsRegulatory News

    HHS, to address insulin price crisis, issues RFP for reimportation

    The US Department of Health and Human Services (HHS) has issued a request for proposals for reimportation of insulin produced in the United States and exported for sale abroad.   The measure, said HHS, is meant to address the fact that “The rising price of insulin, and corresponding rationing of insulin, constitutes an emergency” within the US. The agency noted that insulin prices rose nearly six-fold between 2002 and 2016. One commonly prescribed insulin, said HHS, ha...
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    Drug mutagenicity, proarrhythmic potential addressed in pair of FDA guidances

    The US Food and Drug Administration (FDA) has issued two new draft International Council on Harmonisation (ICH) guidelines for public consultation.   A question-and-answer (Q&A) guidance on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of medicines was published in draft form by FDA on 29 September; the guidance is currently in ICH Step 2b, awaiting consultation from the Council's participating countries. The draft guid...
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    Generic drugmakers get guidance on tentative approvals, CRLs

    Generic drug makers received a final and a draft guidance from the US Food and Drug Administration (FDA) on 28 September that address components of the submission process for an abbreviated new drug application (ANDA).   The draft guidance for generic drugmakers seeks to address problems created when a sponsor fails to respond to an ANDA complete response letter (CRL) within the timeframe stipulated by federal regulations.   The three choices an ANDA sponsor has on...
  • Regulatory NewsRegulatory News

    FDA finalizes blood glucose monitor guidances

    The US Food and Drug Administration (FDA) on Monday finalized guidance providing recommendations for device makers looking to submit 510(k)s for prescription point-of-care and over-the-counter blood glucose monitoring systems (BGMSs), two years after the agency went back to the drawing board to address concerns about its previous guidance.   FDA first issued final guidance on point-of-care and over-the-counter BGMSs in October 2016. In November 2018, in response to ind...
  • Regulatory NewsRegulatory News

    Breast implant label guidance finalized by FDA

    Updated 29 September to add comment from CDRH official The US Food and Drug Administration (FDA) issued final guidance on improving patient information regarding breast implants on 28 September. The final guidance largely echoes draft labeling guidance issued in October 2019, with some clarifications surrounding the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries...
  • Regulatory NewsRegulatory News

    HHS opens pathway to importing Canadian drugs

    The US Department of Health and Human Services (HHS) has issued a final rule that clears a path for importation of some Canadian drugs into the US. The measure follows a 24 July 2020 executive order issued by President Donald Trump that directed the HHS secretary to take action to expand access to lower-cost imported drugs. In a 24 September press release, the US Food and Drug Administration (FDA) said that the final rule would help affordability of drugs for US patient...
  • Regulatory NewsRegulatory News

    Experts call on Hahn to shield FDA from political influence

    More than 30 leading experts and academics in regulatory science and medicine have signed an open letter calling on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to protect the agency from political interference.   The letter comes days after President Donald Trump, who has repeatedly claimed that a coronavirus disease (COVID-19) vaccine could be authorized before the November election and accused FDA staff of being part of “the deep state,” said ...