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  • Regulatory NewsRegulatory News

    Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

    President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those products to reduce US reliance on foreign manufacturing and promoting federal procurement of domestic goods.   Speaking at a Whirlpool Corporation manufacturing plant in Clyde, Ohio, Trump said the US is too dependent on foreign medicines and supplies. “As we’ve seen in this pandemic, the United States must pro...
  • Regulatory NewsRegulatory News

    Pandemic prompts mask, ventilator EUAs from FDA

    This week, the US Food and Drug Administration granted emergency use authorizations (EUAs) to three ventilator-related devices, issued an umbrella EUA for disposable, single-use surgical masks and provided updated information on “in-use time” for certain drugs used to treat patients with COVID-19, the novel coronavirus.   Ventilator-related EUAs The US Food and Drug Administration (FDA) on 4 August issued EUAs for three devices that relate to mechanical ventilation o...
  • Regulatory NewsRegulatory News

    FDA updates bioresearch monitoring e-submission guide

    A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US Food and Drug Administration.   The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework la...
  • ReconRecon

    Recon: Biogen gets FDA priority review for aducanumab; Japan signs deals for AstraZeneca, Novavax COVID-19 vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA grants expedited review to Biogen's Alzheimer's drug ( Reuters ) ( Bloomberg ) ( STAT ) Trump Signs Executive Order to Boost US Production of Essential Medicine ( WSJ ) ( STAT ) Teva CEO Has Doubts About Making Generic-Drug Ingredients in the U.S. ( Barron’s ) Moderna Backtracks to Open Covid Vaccine Trial to Those With HIV ( Bloomberg ) Pfizer to make Gi...
  • Regulatory NewsRegulatory News

    FDA: Most postmarketing requirements, commitments progressing on schedule

    In its latest annual report on drugmakers’ performance in conducting postmarket requirement (PRMs) and postmarketing commitments (PMCs), the US Food and Drug Administration (FDA) says that most studies are progressing on schedule.   Background   A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct following approval, while a PMC is a study or clinical trial that an applicant agrees in writing to conduct, but is not ...
  • ReconRecon

    Recon: Trump expected to sign order to boost US drug manufacturing; FDA approves GSK’s blood cancer drug Blenrep

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Plans Order Seeking to Return Drug Production to US ( Bloomberg ) ( Politico ) ( STAT ) ( Endpoints ) ( Reuters ) FDA commissioner: No matter what, only a safe, effective vaccine will get our approval ( Washington Post ) FDA Adviser: Not Realistic To Expect A COVID-19 Vaccine In 2020 ( NPR ) Trump says coronavirus vaccine possible before Nov. 3 ( Reuters...
  • Regulatory NewsRegulatory News

    LPAD pathway: FDA finalizes guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.   The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited ...
  • Regulatory NewsRegulatory News

    FDA provides guidance on preparation and submission of pediatric study plans

    In a final guidance document, the US Food and Drug Administration provides sponsors with a detailed framework for how to prepare and submit pediatric study plans. The final guidance supplants a draft guidance published in 2016.   The new pediatric study plan guidance follows on from regulations and laws promulgated in the late 1990s and early 2000s that addressed the dearth of pediatric data in drug development. These rules aimed to increase pediatric studies for exclu...
  • RoundupsRoundups

    FDA Approvals Roundup: Monjuvi, Spravato, Epidiolex

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Monjuvi okayed as novel therapy for diffuse large B-cell lymphoma MorphoSys’ Monjuvi (tafasitamab-cxix IV infusion) has been approved for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).   The novel CD19-directed cytolytic antibody is indicated in combination with lenalidomide for patients with DLBCL, i...
  • ReconRecon

    Recon: US strikes $1B deal for J&J COVID-19 vaccine; Prosecutors seek up to $18B from Purdue

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to pay $1 billion for 100 million doses of Johnson & Johnson's COVID-19 vaccine candidate ( Reuters ) ( FT ) US government begins two trials testing Eli Lilly’s coronavirus antibody drug ( CNBC ) Justice Department Seeks as Much as $18.1 Billion From Purdue Pharma ( WSJ ) ( Reuters ) Novavax’s Covid-19 vaccine shows promising immune response, early data sho...
  • ReconRecon

    Recon: Abbvie cans pacts with Voyager; Bayer sees compounded troubles with COVID-19

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Generic drug approvals still winning the pandemic at US FDA ( Pink Sheet ) BARDA Begins Stockpiling APIs For Critical Drugs ( Pink Sheet ) Report: GoodRx files for IPO ( MedCity News ) CymaBay Reports Positive Results for Seladelpar in Patients with Primary Biliary Cholangitis ( Global Genes ) BARDA drafts Fujifilm Diosynth into its vaccine production effort, of...
  • Regulatory NewsRegulatory News

    FDA touts advanced manufacturing to address COVID shortfalls

    Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the COVID-19 pandemic, Stephan Hahn, Food and Drug Administration (FDA) commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website. “The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, whic...