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

 
  • Regulatory NewsRegulatory News

    Patient-Focused Drug Development: New FDA Draft Guidance Delves Into What’s Important

    The US Food and Drug Administration (FDA) on Monday published the second in a series of four guidance documents on patient-focused drug development, with this latest draft helping sponsors identify what is most important to patients with respect to their experience with disease burden and treatment. In determining what’s important, FDA recommends that sponsors use qualitative research methods, which can generate in-depth thoughts from patients in their own words through...
  • Regulatory NewsRegulatory News

    FDA Explains What Mobile Apps Are No Longer Devices

    A section of the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and removed certain software functions from the definition of a medical device. In addition to drafting new guidance on clinical decision support software, the US Food and Drug Administration (FDA) on Thursday released final guidance explaining what digital health products are no longer devices and are no longer subject to FDA regulations. Examples of such...
  • Regulatory NewsRegulatory News

    Electronic Device Submissions: FDA Drafts Guidance

    Thanks to the FDA Reauthorization Act of 2017 (FDARA) , the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance with “both binding and nonbinding provisions” related to electronic submissions for medical devices. At the outset of the seven-page draft, FDA warns that it has concluded “that it is not feasible to describe and implement the electronic format(s) that would apply” to all the device submissions in one guidance document, so this g...
  • Regulatory NewsRegulatory News

    Patient Engagement in Device Trials: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Monday released new draft guidance explaining how sponsors can improve the design and conduct of medical device clinical investigations by using patient experience, perspectives and other relevant information. The 10-page draft mainly addresses four questions: What approaches might sponsors use to engage patient advisors (defined by FDA as those who have dealt with or are dealing with a particular condition but are not inv...
  • Regulatory NewsRegulatory News

    FDA Finalizes ALS Drug Development Guidance

    The US Food and Drug Administration (FDA) on Monday finalized guidance to assist in the clinical development of treatments for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The 11-page guidance, which finalizes a draft version from February 2018, includes information on general development, safety and effectiveness considerations, as well as specific effectiveness trial considerations. The guidance incorporates parts of a guidance put toget...
  • Regulatory NewsRegulatory News

    CDRH Takes First Step to Operationalize New Safety and Performance Based Pathway

    As part of work to implement the optional Safety and Performance Based Pathway for medical devices, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday issued four draft guidance documents identifying performance criteria and testing methodologies for certain devices within four class II device types. CDRH also released updated final guidance explaining the new pathway and to further clarify the information FDA wil...
  • Regulatory NewsRegulatory News

    Citizen Petitions Delaying Approvals: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a stay of agency action are submitted with the primary purpose of delaying the approval of a pending generic drug, biosimilar or 505(b)(2) application. The final guidance comes as FDA in February explained its concerns to Congress that such petitions are often...
  • Regulatory NewsRegulatory News

    MHRA Updates No-Deal Brexit Device Guidance

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday updated its no-deal Brexit guidance for medical devices, adding a new section on the role of the “UK Responsible Person.” According to the guidance, the UK Responsible Person, who must be established in the UK, acts on behalf of a non-UK manufacturer to carry out tasks for the manufacturer, which include registering with the  MHRA  before a device is placed on the UK market. “Only a manu...
  • Regulatory NewsRegulatory News

    Population Pharmacokinetics: Drugmakers Seek Clarity and Additions to Revised FDA Guidance

    About a dozen drugmakers and industry groups recently offered their opinions on a revised US Food and Drug Administration (FDA) draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. The comments largely seek specific tweaks to the 23-page revised draft, which was released in July , although some of the comments also seek further clarity and new additions to the guidance. Indu...
  • Regulatory NewsRegulatory News

    FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development

    The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products. When finalized, the guidance documents will represent the current thinking of FDA on, among other things, the product-specific design of bioequivalence studies to support abbreviated new drug applications. Among th...
  • Regulatory NewsRegulatory News

    510(k) Submissions: CDRH Releases Four Final Guidances

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released four final guidance documents on the Special 510(k) program, the abbreviated 510(k) program, how to format traditional and abbreviated 510(k)s and CDRH’s refuse to accept policy for 510(k)s. As part of a wider, ongoing push to modernize FDA’s 510(k) program, the final guidance documents provide more clarity on several programs the agency has been working on...
  • Regulatory NewsRegulatory News

    FDA Developing Guidance on Real-World Data Quality Issues, Officials Say

    As the US Food and Drug Administration (FDA) grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations. Aliza Thompson and Mary Ross Southworth of the Division of Cardiovascular and Renal Products w...