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  • Regulatory NewsRegulatory News

    OPDP sends first untitled letter of 2020 to Xeris over Gvoke TV spot

    Xeris Pharmaceuticals last week received the first untitled letter sent by the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) in 2020 over claims made in a television ad for its Gvoke (glucagon) pre-filled syringe.   The letter is only the second enforcement letter sent by OPDP this year after the office warned Outlook Pharmaceuticals for omitting risk information in a sponsored link on Google, marking a particularly light year for...
  • Regulatory NewsRegulatory News

    EMA goes all-virtual for remainder of 2020

    The European Medicines Agency (EMA) has announced that all its committee and working party meetings will be held virtually through the end of 2020.  Stakeholder events will also be virtual through the end of the year as well, although a few events will have an in-person speaker panel.   “EMA has taken steps to reduce the further spread of COVID-19, with the aim of protecting staff, delegates and experts and playing our part as responsible citizens in our host country, ...
  • RoundupsRoundups

    FDA Roundup: Enspryng

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Enspryng approved for neuromyelitis optica spectrum disorder Genentech’s Enspryng (satralizumab-mwge injection) has received approval for treating the rare autoimmune disease, neuromyelitis optica spectrum disorder (NMOSD), in adults who are positive for the anti-aquaporin-4 antibody (anti-AQP4 positive).   The approval is the third in little...
  • Regulatory NewsRegulatory News

    FDA updates respirator EUA workflow

    Manufacturers and distributors of respirators for health care workers during the coronavirus pandemic received detailed updates, including a new flowchart, from the US Food and Drug Administration (FDA).   The flowchart clarifies procedures for manufacture and distribution of a variety of respirators under the emergency use authorizations (EUAs) for respirators that FDA has issued during the COVID-19 pandemic. (RELATED : Pandemic prompts mask, ventilator EUAs from F...
  • Regulatory NewsRegulatory News

    PDUFA meeting airs industry's take on FDA communications

    A required review of the US Food and Drug Administration’s communication with industry found that communication was overall timely, collaborative and effective at moving development programs down the road. However, feedback from industry and details of an outside consultant’s report also identified some notable gaps.   The consultant-prepared communications assessment presented in an 11 August public meeting fulfilled requirements of the Prescription Drug User Fees Ame...
  • Regulatory NewsRegulatory News

    FDA trims reserve testing quantity requirements

    Reflecting changes in testing technology, a new and immediately effective guidance from the US Food and Drug Administration (FDA) updates the agency’s approach to retention of reserve samples for bioavailability and bioequivalence testing, generally reducing the amount of drug product that applicants must retain.   An interim rule issued in 1990 and made final in 1993 required applicants or contract research organizations (CROs) to retain an amount of test article and ...
  • Regulatory NewsRegulatory News

    Draft AML guidance takes targeted therapies into account

    The US Food and Drug Administration(FDA)  has issued a new draft guidance for developers of drugs and biologics to treat acute myeloid leukemia (AML).   The new draft guidance takes into account a shift in the treatment landscape for AML as new targeted treatments are being developed for this and other cancers. "In some cases, these newer approaches may extend survival without the prospect for cure, but extending survival may be a meaningful benefit for patients who wo...
  • Feature ArticlesFeature Articles

    FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic

    This article discusses the evolution and implementation of the emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for diagnostic devices during the COVID-19 pandemic in the United States. The author suggests that this limited oversight will affect future requirements for demonstrable superiority claims after the EUAs are terminated and diagnostics for the virus undergo increased scrutiny by the agency for marketing authorization. She covers the ...
  • Regulatory NewsRegulatory News

    Penalty policy for trial reporting violations finalized

    The US Food and Drug Administration has finalized guidance for civil money penalties it may levy for clinical trial data bank reporting violations.   The final document follows a September 2018 draft that addressed the question of how FDA’s Centers should deal with responsible parties who breach federal regulations requiring accurate and complete registration of clinical trials and reporting of results on the www.clinicaltrials.gov website.   This final guidance ...
  • Regulatory NewsRegulatory News

    Unauthorized home COVID test kits targeted by FDA

    Several companies marketing a variety of home tests for COVID-19 were warned by the US Food and Drug Administration (FDA) for misbranding and impermissible marketing. The letters, issued this week, gave the firms 48 hours to take corrective action.   The FDA warned US-based AkivaMed on 23 July for offering a “COVID-19 Antibody Rapid Test Kit” to consumers for at-home blood test collection and analysis.   “We remind you that, to date, FDA has not approved, cleared...
  • Regulatory NewsRegulatory News

    Stakeholders call for regulatory clarity in rare disease research network

    Stakeholders weighing in on a proposed rare disease clinical trials network called for regulatory clarity, smart use of existing resources, and a move toward harmonized trial standards and assessments.   As part of the launch of the US Food and Drug Administration (FDA)’s Rare Disease Cures Accelerator , the agency asked for stakeholder input on how FDA and other agencies can achieve a more cooperative approach in supporting the drug development pipeline for rare dise...
  • RoundupsRoundups

    FDA Roundup: Blenrep, Olinvyk, Lampit

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Blenrep okayed for multiple myeloma in heavily pretreated adults GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf injection) has received accelerated approval for relapsed or refractory multiple myeloma in adults with previous failed treatments, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody.   Blenrep ...