• RoundupsRoundups

    Asia-Pacific Roundup: TGA revises guidance on clinical evidence for comparable devices

    Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, almost totally rewriting the section on comparable devices including substantially equivalent products.   A comparable device is a product “with related function chosen by the manufacturer to inform the clinical evaluation of the device in question,” according to the new section. The first step in the process is to choose a suitable comparable device. So...
  • ReconRecon

    Recon: FDA approves Supernus ADHD drug Qelbree; Valneva to begin Phase 3 trial of its COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna Vaccine Production Pace to Increase at CMO Catalent ( WSJ ) ( Endpoints ) Walgreens Not Following US Guidance on Pfizer Vaccine Spacing ( NYTimes ) Biden Tax Plan Seen Hitting Tech, Pharmaceutical Companies ( Bloomberg ) Biden to speed up eligibility for vaccine as US hits milestone ( Reuters ) Former USAID chief tapped to lead vaccine diplomacy effor...
  • Regulatory NewsRegulatory News

    FDA offers guidance on generic drug development during COVID

    The US Food and Drug Administration (FDA) on Monday released a new questions and answers guidance for generic drugmakers addressing generic product development and abbreviated new drug application (ANDA) submissions and assessments during the COVID-19 public health emergency.   “FDA recognizes that the COVID-19 public health emergency may impact the development of generic drug products, interrupt or delay ANDA applicants’ bioequivalence studies, and impact the submissi...
  • Feature ArticlesFeature Articles

    Talking to decision makers: What to say and how to say it

    The ability to confidently convey an idea and persuade others of its benefits to your organization is key to achieving success. This article discusses ways to use persuasive skills, the importance of physical presence, and tips for maintaining a positive attitude.   Introduction How often does a decision maker or specifically, your manager, reject your ideas? Have you ever wondered why co-workers with inferior proposals have their requests approved? You are convinc...
  • Regulatory NewsRegulatory News

    HHS’ proposed 510(k) exemption proves the need for regulatory science

    Authors of a recent commentary in Nature Medicine have come out against a federal notice that would exempt more than 91 medical devices from premarket notification 510(k) requirements.   The notice , released by the Department of Health and Human Services (HHS) on 15 January, was published in the last days of the Trump administration without consulting the US Food and Drug Administration (FDA). It is currently on hold pending review per a “regulatory freeze” memora...
  • ReconRecon

    Recon: US puts J&J in charge of Emergent facility; FDA extends review of AbbVie’s Rinvoq for atopic dermatitis

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca ( Reuters ) ( CNN ) ( NYTimes ) US searches for new AstraZeneca vaccine producer after Emergent mix-up ( Politico ) Emergent gets $23 million additional order for vaccine production ( Reuters ) Acadia preps for battle as the FDA rejects a potential blockbuster application ( Endpoint...
  • Regulatory NewsRegulatory News

    Biosimilars industry weighs in on BsUFA II interim assessment

    Three biopharmaceutical trade associations have weighed in with generally positive positions on an interim assessment of how the US Food and Drug Association has fared in its efforts to increase transparency and improve communication in its process for reviewing and approving biosimilars.   The comments follow a 27 January public meeting hosted by FDA that shared results of an external review of the agency’s Program for Enhanced Review Transparency and Communication fo...
  • Regulatory NewsRegulatory News

    FDA seeks to improve on EUA processes, inspections following PREPP review

    The US Food and Drug Administration (FDA) on Friday said it will work to improve on five areas of its COVID-19 pandemic response to make the agency more resilient in the current and future public health emergencies.   “As we continue our COVID-19 response, it is critical that we learn from both our successes and the challenges we experienced, to best improve our operations,” said Acting FDA Commissioner Janet Woodcock.   The five areas cover FDA’s emergency use aut...
  • ReconRecon

    Recon: Moderna cleared to increase vaccine doses per vial; FDA investigating J&J vaccine mix-up at Emergent facility

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci says US may not need AstraZeneca COVID-19 vaccine ( Reuters ) FDA allows Moderna to put more coronavirus vaccine doses in each vial ( Politico ) ( Reuters ) ( FDA ) FDA Probes Cause of Failed Johnson & Johnson Covid-19 Vaccine Batch ( WSJ ) Why the Biden administration might not want to be content with just an acting FDA commissioner ( Endpoints ) Johns...
  • RAPS' LatestRAPS' Latest

    Regulatory Intelligence 101 authors stress importance of actionable info, communications, creativity

    RAPS recently brought together three leading authors of the just-released, newly revised third edition of Regulatory Intelligence 101 to discuss the book and the practice of regulatory intelligence (RI). Author and global RI expert, Céline Rodier Seguy, joined lead editors, Daanish Ashraf and Bill Sietsema to answer questions and provide insight on keeping up with complex and constantly changing regulatory information, during a live webcast moderated by RAPS Senior Edi...
  • Regulatory NewsRegulatory News

    European Commission kicks off review of pharmaceutical legislation

    As part of its broader pharmaceutical strategy, the European Commission on Tuesday released a roadmap for its planned revision of the EU’s aging pharmaceutical legislation next year.   The Commission adopted its pharmaceutical strategy last November following a public consultation earlier in the year. “[The strategy] is intended to make the European pharmaceutical system patient-centered, future-proof and crisis-resistant,” the Commission writes. (RELATED: European C...
  • FDA, EMA team up on pediatric oncology drug development template

    In a move that dovetails with other cooperative efforts in regulation of pediatric oncology drugs, regulators in the US and Europe have come together to provide a common template for drugmakers to use when planning clinical trials for pediatric cancer drugs.   A new Common Commentary template gives a framework for seeking scientific advice from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on new Pediatric Investigation Plans ...