RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

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    Generic drug makers received a final and a draft guidance from the US Food and Drug Administration (FDA) on 28 September that address components of the submission process for an abbreviated new drug application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   The draft guidance for generic drugmakers seeks to address problems created when a sponsor fails to respond to an ANDA complete response letter (CRL) within the timeframe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

    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 to track real-world data on breast implants.   FDA reco...
  • 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 ...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on clinical trials, drug development for EoE

    The US Food and Drug Administration (FDA) has finalized a guidance for industry on development of drugs and therapeutic biologics for treating eosinophilic esophagitis (EoE), a chronic, allergic inflammatory disease of the esophagus, for which there are currently no approved therapies.   The guidance addresses the agency’s thinking on clinical trials and development programs, focusing on trial population and design, efficacy and safety, as well as pediatric considera...
  • FDA launches digital health center of excellence

    A new digital health Center of Excellence within the US Food and Drug Administration (FDA) aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.   The DHCoE’s website details services offered, including examples of CDRH-specific, FDA-wide and external efforts to “translate digital advances into tools that benefit consumers.” The Center is housed within FDA’s Center for Devices and Radiological Health (...
  • Regulatory NewsRegulatory News

    Hahn pledges no politics in COVID vaccine decisions

    Testifying before the Senate Health, Education, Labor and Pensions Committee on Wednesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said that politics will not play a part in the decision to approve or authorize a vaccine for coronavirus disease (COVID-19).   Hahn stressed that he supports science and has “100% confidence” in his staff, and said that, “FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous ...
  • Regulatory NewsRegulatory News

    FDA updates benzodiazepine boxed warning

        The US. Food and Drug Administration (FDA) is requiring that the boxed warning on benzodiazepines be updated to provide a uniform description of the risks associated with all medications in the class.   On 23 September 2020, FDA announced in a Drug Safety Communication that current prescribing information for benzodiazepines "does not provide adequate warnings about the serious risks and harms associated with these medicines, so they may be prescribed and used ...
  • Feature ArticlesFeature Articles

    Gene therapies – The regulatory road to individualized medicine

    This article discusses the evolving US regulatory landscape for gene therapies. The author explores the recent history and developmental paradigm shifts for gene therapy products and concludes with advice for abbreviated development and thoughts on policies that will create a sustainable gene therapy ecosystem. The author examines the paradigm shift of clinical trial and lifecycle management for gene therapies and considers the changes to the US regulatory framework that ...
  • Regulatory NewsRegulatory News

    Generic drugmakers get cannabidiol bioequivalence guidance from FDA

    Manufacturers who seek to produce generic versions of cannabidiol oral solution received guidance from the US Food and Drug Administration (FDA) on establishing bioequivalence with the reference listed drug.   The guidance follows the June 2018 approval of Epidiolex (cannabidiol) oral solution to treat seizures associated with two rare and serious types of childhood epilepsy. Epidiolex was also approved to treat a third seizure condition, tuberous sclerosis complex, in...
  • Regulatory NewsRegulatory News

    Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance

    Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel coronavirus pandemic, according to an updated guidance from the US Food and Drug Administration (FDA).    The updated information came on 21 September 2020 in the form of a new addition to the questions and answers in the FDA's guidance on conduct of clinical trials of medical pro...