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  • Regulatory NewsRegulatory News

    Cord blood firm warned by FDA on Zika screening

    A warning letter from the US Food and Drug Administration (FDA) warned a Puerto Rico-based firm for multiple violations related to human umbilical cord blood collection.   Banco Vida Corporation, located in San Juan, was inspected in September 2019 by investigators from FDA’s Center for Biological Evaluation and Research (CBER).  The increased risk for Zika virus for residents of Puerto Rico makes blood products from those individuals ineligible for use in human cell, ...
  • Regulatory NewsRegulatory News

    Study: FDA details high global drug quality

      A quality improvement study led by the US Food and Drug Administration (FDA) found that over 200 difficult-to-manufacture drug product samples met US standards for dosage unit uniformity and dissolution.   The 252 products that were sampled in the largest such study to date included 35 innovator and 217 generic drug samples. In all, the products contained 17 different active pharmaceutical ingredients (APIs) and the samples originated from 46 firms.   Adam Fish...
  • Regulatory NewsRegulatory News

    ANDA consolidation process updated in new MAPP

    The US Food and Drug Administration (FDA) has updated its manual of policies and procedures (MAPP) for the review of requests to consolidate previously approved generic drug applications.   The revised MAPP , entitled “ Consolidation of ANDAs by the Office of Generic Drugs ,” replaces the original October 2015 version of the document. The revisions clarify the process for sponsors of Abbreviated New Drug Applications (ANDAs) who wish to consolidate several ANDAs for d...
  • Regulatory NewsRegulatory News

    FDA revokes umbrella EUA for some patient barrier enclosures

    On 20 August, the US Food and Drug Administration (FDA) revoked the umbrella emergency use authorization (EUA) it had previously issued for passive, non-negative pressure protective barrier enclosures that are intended to be a physical barrier preventing healthcare provider exposure to airborne pathogens.   The EUA was issued on 1 May 2020 during the public health emergency of the coronavirus pandemic.  The passive protective barriers included in the EUA, consisting ...
  • 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...
  • 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 ...