RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    Updated: Redfield endorses ACIP's first-wave COVID-19 vaccine priorities

    Meeting the week before an FDA advisory committee convenes to consider the first application for emergency use authorization of a COVID-19 vaccine, an advisory committee of the Centers for Disease Control and Prevention (CDC) voted 13-1 to allocate the first vaccine rounds to health care workers and residents of long-term care facilities.   “We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over fina...
  • Regulatory NewsRegulatory News

    MDCG clarifies remote audit expectations for notified bodies

    The European Commission’s Medical Device Coordination Group (MDCG) released a new questions and answers document clarifying expectations for notified bodies looking to conduct remote audits of medical device manufacturers during the COVID-19 pandemic.   The document is meant to answer “operational and practical implementation” questions raised in response to the committee’s MDCG 2020-4 guidance released in the early months of the pandemic. (RELATED: Notified body aud...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the  United Kingdom  and  Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in the United States ,  Japan  and Australia.   Three therapeutics have received emergency use authorizations (EUAs) in the US. Convalescent plasma, which was authorized by the Food and Drug Administration (FDA) on 23 August and is subject to updated...
  • ReconRecon

    Recon: Lilly, UnitedHealth launch COVID antibody trial; Bahrain authorizes Pfizer-BioNTech vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA chief had 'robust discussion' with White House about vaccine timelines ( Reuters ) How key decisions slowed FDA’s review of Covid-19 vaccine — but also gave it important data ( STAT ) Pfizer Shares Gain Amid Pushback on COVID Vaccine Rollout Headlines ( The Street ) ( Fierce ) Pfizer Slashed Its Original Covid-19 Vaccine Rollout Target After Supply-Chain O...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    Updated Regulatory Writing Book Now Available

    It isn’t easy to be a highly effective regulatory writer, but clear, well-written documentation is a critical part of bringing essential medicines and medical products to market. In RAPS’ newly released, Regulatory Writing: An Overview, Second Edition , aspiring and experienced writers alike will find expert guidance and advice that is easy to apply. Completely updated from the previous edition, Regulatory Writing covers content development for regulatory documents...
  • Regulatory NewsRegulatory News

    Shuren previews 2021 priorities for CDRH

    With much of his center’s 2020 agenda on hold due to the COVID-19 pandemic, Jeffrey Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiologic Health (CDRH) on Thursday shared some of his hopes for next year on a call with the Alliance for a Stronger FDA.   “COVID-19 has essentially disrupted the trajectory of the medical device program in 2020. If you really think about it, 2021 is going to be a bit more of a reset,” Shuren said,...
  • Regulatory NewsRegulatory News

    Azurity garners OPDP untitled letter for problematic emails

    Marketing Xatmep (methotrexate oral solution) to health care providers without giving a full presentation of the drug’s serious risks has garnered an untitled letter from the US Food and Drug Administration (FDA) for Azurity Pharmaceuticals.   In the letter dated 24 November 2019, FDA’s Office of Prescription Drug Promotion (OPDP) references promotional materials sent to healthcare professionals via email by Massachusetts-based Azurity.   Xatmep is indicated as par...
  • Regulatory NewsRegulatory News

    FDA finalizes feedback processes for combo products

    Developers of combination products have new final guidance from the US Food and Drug Administration about requesting feedback from the agency during the full product development cycle.   In response to feedback received during the consultation period on the January 2020 draft guidance, FDA has adjusted the final guidance to give developers more information about the best use of combination product agreement meetings (CPAMs) as well as how agreements reached through CPA...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. The Herculean effort means that a fast-tracked vaccine could come to market anywhere from the  end of 2020  to the middle of  2021 .   Few vaccines have been authorized to date. Pfizer/BioNTech's BNT162b2 received temporary authorization from the UK Medicines and Healthcare products Regulatory Agency on 2 December. Sputnik V – formerly kno...
  • RoundupsRoundups

    Euro Roundup: EMA clarifies label flexibility for COVID vaccines

    COVID-19 vaccines may be distributed in English-language only  packaging in Europe under temporary measures designed to ensure speedy deployment of vaccines against the coronavirus, according to a question-and answer-document published by the European Medicines Agency (EMA).   Based on principles set out in a statement from the European Commission, EMA will permit manufacturers to provide COVID-19 vaccines with outer and immediate packaging that only carries text in ...
  • ReconRecon

    Recon: Moderna to begin testing COVID vaccine in children ages 12-17; Merck KGaA partners with Artios to develop cancer drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Raimondo emerges as frontrunner for HHS secretary ( Politico ) FDA Head Defends Covid-19 Vaccine-Approval Process ( WSJ ) Moderna Plans to Begin Testing Its Coronavirus Vaccine in Children ( NYTimes ) FDA chief meets with Meadows again as Trump remains frustrated with pace of vaccine approval ( CNN ) The COVID Vaccines Are Approaching. Is the FDA Ready to Ins...
  • Regulatory NewsRegulatory News

    MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted temporary authorization on 2 December to Pfizer and BioNTech’s mRNA-based BNT162b2 COVID-19 vaccine, vaulting ahead of regulators in the US and EU.   The temporary authorization is “batch-specific” and applies only to a single batch of the vaccine. Subsequent batches must be approved by MHRA and must meet the same authorization conditions as the initial batch. MHRA said the decision was mad...