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  • Regulatory NewsRegulatory News

    Six more months tacked onto regenerative medicine enforcement date

        The end of a discretionary enforcement period for regenerative medicine products was pushed back by another 6 months, according to a final guidance issued today by the US Food and Drug Administration (FDA).   Today’s updated guidance shifts the enforcement date but otherwise leaves unchanged a 2017 guidance addressing regulatory considerations for “minimal manipulation” and “homologous use” of human cells, tissues and cellular and tissue-based products (HCT/P...
  • Regulatory NewsRegulatory News

    FDA approves pooled sampling for COVID-19 test

    Pooled sampling of COVID-19 swab specimens is now allowed under a reissued emergency use authorization (EUA) for the Quest Diagnostics SARS-CoV-2 rRT-PCR test, the US Food and Drug Administration (FDA) announced on 18 July.   Under the reissued EUA, four samples may be processed together in a batch, reducing the number of tests run and using fewer testing supplies. If the pooled sample is negative, no more testing would be required. If the pooled sample is positive, th...
  • Regulatory NewsRegulatory News

    Project Patient Voice a focus of ASCO-FDA workshop

    A day-long workshop co-sponsored by the US Food and Drug Administration (FDA) and the American Society for Clinical Oncology (ASCO) focused on clinical outcome assessments in cancer clinical trials. A key topic of the day’s work was the pilot version of Project Patient Voice , a new attempt to create a flexible, searchable, accurate, and understandable website for members of the public who wish to learn about patient experience data. The website is meant to give patients ...
  • Regulatory NewsRegulatory News

    Multi-stakeholder team addresses tumor mutational burden harmonization

    Harmonizing measurement and reporting of biomarkers in oncology represents a cross-disciplinary challenge that also cuts across industry, regulatory bodies, academic, and clinical practice. As cancer therapy becomes increasingly targeted, the need for validated biomarker measurement becomes more pressing.   In first addressing how biomarkers can be used in conjunction with tumor treatment, said Richard Pazdur, MD, the US Food and Drug Administration faced “a considerab...
  • Regulatory NewsRegulatory News

    House committee advances bills aimed at orphan exclusivity, generic labeling and continuous manufacturing

    The House Energy and Commerce Committee on Wednesday advanced 17 health-related bills for consideration by the House, several of which have implications for the US Food and Drug Administration’s (FDA) oversight of orphan drugs, imported medical devices and labeling.   (RELATED: House committee discusses bipartisan bills on orphan exclusivity, generic drug labels and more , Regulatory Focus 29 January 2020).   “These bills will expand coverage and access to car...
  • FDA guidance addresses ultrasonic prostate ablation submissions

    A new final guidance from the US Food and Drug Administration (FDA) addresses clinical testing and clinical data collection to support marketing authorizations for high intensity ultrasound systems to ablate prostate tissue.   The agency clarified in the guidance that the scope is limited to clinical investigations that support authorization to market the devices for “general indications of prostate tissue ablation systems,” including those regulated under the PLP...
  • Feature ArticlesFeature Articles

    Update on RMAT designations

    This article discusses the scope and purpose of the special designation for regenerative medicine advanced therapies (RMAT) created by the passage of the 21st Century Cures Act. The authors explain the benefits expected to be realized with RMAT and provide a tally of products receiving the special designation to date and a current count, by year, of products for which RMAT designation has been requested.   Introduction Section 3033 of the 21st Century Cures Act, titl...
  • Regulatory NewsRegulatory News

    Electronic device submissions addressed in FDA guidance

    A new final guidance from the US Food and Drug Administration (FDA) lays the framework for electronic submissions for medical devices. The agency advised that more specifics about the nuts and bolts of electronic submissions, as well as the timing of implemention, will be provided in upcoming guidances.   One guidance document is insufficient for describing and implementing electronic formats for all types of submissions covered under the statutory requirements, said F...
  • RoundupsRoundups

    FDA Approvals Roundup: Qwo, Tremfya, Dysport

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Qwo nabs approval for first injectable cellulite treatment Endo International’s Qwo (collagenase clostridium histolyticum-aaes [CCH] injection) has been approved as the first injectable therapy for moderate to severe cellulite in adult women.   The approval was based on findings from two identical double-blind, placebo-controlled trials in...
  • Regulatory NewsRegulatory News

    FDA adds three tropical diseases to PRV list, rejects two

    Three new conditions were added today to the list of tropical diseases for purposes of obtaining a tropical disease Priority Review Voucher (PRV) from the US Food and Drug Administration (FDA). The agency added brucellosis to the list, as well as two foodborne trematode infections, opisthorchiasis and paragonimiasis.   The agency determined that two other diseases, coccidioidomycosis and clonarchiasis, did not meet statutory criteria for tropical disease designation un...
  • Regulatory NewsRegulatory News

    FDA updates COVID-19 therapeutics website

    The US Food and Drug Administration (FDA) has to date reviewed over 230 trials of potential therapeutics to treat the novel coronavirus (COVID-19), according to a blog post by FDA commissioner Stephen Hahn, MD and colleagues. Over 510 COVID-19-directed drug development programs have reached the planning stage.   In the blog, agency officials provide an update on FDA’s Coronavirus Treatment Acceleration Program (CTAP), a set of resources designed to allow cross-agency...
  • Regulatory NewsRegulatory News

    House spending bill would give FDA drug recall authority

    The US House Committee on Appropriations approved a $3.212 billion budget for the Food and Drug Administration (FDA) on a voice vote Thursday. The budgeted amount is part of the fiscal year 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill, which moved out of the Appropriations Committee on a voice vote.   The bill will now be placed on the calendar for consideration by the full House of Representatives. (RELATED: House prop...