• Regulatory NewsRegulatory News

    FDA temporarily halts inspections due to omicron

    As the US and other countries grapple with record-high COVID-19 cases driven by the omicron variant, the US Food and Drug Administration (FDA) has once again halted many of its domestic and foreign inspections.   Just before the New Year, on 29 December, FDA “implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread ...
  • ReconRecon

    Recon: Pfizer, BioNTech to develop mRNA shingles shot; French court backs class action over Sanofi’s Depakine drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA pauses domestic drug inspections again, this time to protect against Omicron ( Endpoints ) ( Fierce ) FDA Nominee’s Committee Vote Set ( Politico) Third former GSK scientist pleads guilty to conspiring to steal trade secrets ( Endpoints ) Why the conviction of Elizabeth Holmes hinged on defrauding Theranos investors, not patients ( STAT ) US Biosimilar A...
  • Regulatory NewsRegulatory News

    Computational modeling and simulation: FDA outlines framework for assessing credibility

    With the use of computational modeling and simulation (CM&S) in medical device submissions on the rise, the US Food and Drug Administration (FDA) last month issued draft guidance detailing a risk-based framework for how to assess the credibility of such models.   Within the 36-page guidance, the agency lays out a nine-step generalized framework for assessing the credibility of computational modeling in a regulatory submission and provides additional details on the key ...
  • ReconRecon

    Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More than 1 million Americans were diagnosed with COVID over the long holiday weekend ( NPR ) ( Reuters ) Elizabeth Holmes is found guilty of four counts of fraud ( NYT ) ( POLITICO ) The Epic Rise and Fall of Elizabeth Holmes ( NYT ) Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US ( Fierce ) CDER, CBER Approve Total...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA asks drugmakers to mitigate cybersecurity weakness amid ‘active malicious exploitation’

    Australia’s Therapeutic Goods Administration (TGA) has asked drugmakers and other stakeholders to detect and mitigate a cybersecurity vulnerability. TGA made the request after learning of “widespread and active malicious exploitation” of the critical vulnerability in an open-source logging library.   Developers across multiple industries use Apache's Log4j to track activity in their software applications and online services. The log serves as a journal of activity that...
  • Regulatory NewsRegulatory News

    FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies

    The US Food and Drug Administration (FDA) is proposing to give medical device makers 180-days’ notice before terminating emergency use authorizations (EUAs) and phasing out its enforcement policies for medical devices issued during the COVID-19 public health emergency (PHE).   The transition plan comes in the form of two draft guidances issued in late December, in which FDA explains that the transition policies are intended to “prepare manufacturers and other stakehold...
  • Regulatory NewsRegulatory News

    ICH releases revised Q9 guideline to improve risk assessments

    The International Council for Harmonization (ICH) issued a revision of the Q9 guideline that aims to address the shortcomings of the current guideline. The goal of the revision is to provide “more scientific and robust applications of quality risk management principles (QRM)” leading to “fewer quality defects and recalls” and reduced costs for the pharmaceutical industry, according to an ICH business plan .   The ICH Q9(R1) guideline was published on the European Me...
  • ReconRecon

    Recon: FDA clears Pfizer booster for 12- to 15-year-olds; Teva found liable in New York opioid trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The FDA clears booster shots for 12- to 15-year olds ( NYTimes ) ( STAT ) ( Reuters ) ( WashingtonPost ) FDA authorizes new Merck Covid-19 pill despite scientists' concerns on its mechanism of action ( Endpoints ) FDA authorizes the first at-home pills from Pfizer to treat Covid-19 ( Endpoints ) Interval between Moderna COVID-19 vaccine second shot and booster...
  • Feature ArticlesFeature Articles

    December’s Regulatory Focus: Advertising, promotion, and labeling

    Feature articles during December focused on advertising, promotion, and labeling (APL), examining regulatory review of advertising on streaming media, the role of the regulatory A&P professional, the importance of metrics in APL, and the regulatory outlook for telehealth A&P. Also included is the second part of a two-part series on EU regulation of herbal products, examining quality, safety and efficacy, and postmarket surveillance.   Last year this time, the issue co-...
  • RoundupsRoundups

    Euro Roundup: Commission acts to stop Brexit from disrupting supply of medicines

    The European Commission has set out how it plans to stop Brexit from disrupting the supply of drugs in certain markets, most notably Northern Ireland. The plan builds on the proposal the Commission made in October as part of the multiple rounds of negotiations with the United Kingdom.   Under parts of the Brexit agreement designed to avoid a hard border on Ireland, Northern Ireland, which is part of the UK, is subject to European Union regulations. The situation has ...
  • RoundupsRoundups

    FDA Approvals Roundup: Apretude, Vyvgart, Tezspire

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals  Apretude cleared for HIV pre-exposure prevention  Viiv’s Apretude (cabotegravir extended-release injectable suspension) has been  approved  for use in at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.  Approval of Apretude was based on safety and efficacy findings from two randomized, dou...
  • Feature ArticlesFeature Articles

    The regulatory outlook for telehealth advertising and promotion

    The global pandemic has increased the use of telehealth and accelerated its acceptance into mainstream healthcare. However, the regulatory landscape has yet to fully catch up with this expansion of telehealth. This article discusses some of the potential advertising and promotional regulatory implications as telehealth becomes a mainstay in the ever-evolving healthcare sector. The article explores the advertising and promotion of off-label drug prescriptions by telehealth ...