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  • Regulatory NewsRegulatory News

    CBER outlines another slim guidance agenda for 2022

    For the second year in a row, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has laid out a relatively slimmed-down guidance agenda, featuring just 13 draft and final guidances the center plans to issue in 2022.   The list is down slightly from the initial 14 guidances that made the list in 2021, and down more significantly from the 31 guidances the center listed in 2020. As with previous years, there are only a handful ...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA seeks feedback on adverse event data

    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into how to improve access to medicine adverse event data. The agency is proposing to enable sponsors to view and export such data from its systems.   Currently, sponsors cannot automatically view or export de-identified adverse event data held in TGA systems; instead, they must manually search the public Database of Adverse Event Notifications - Medicines or email TGA. After receiving a reque...
  • ReconRecon

    Recon: FDA halts use of two monoclonal antibodies ineffective against Omicron; J&J expects 46% jump in COVID vaccine sales in 2022

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Halts Use of Two Treatments Ineffective Against Omicron ( Bloomberg ) ( FDA ) ( Endpoints ) ( Reuters ) As Pfizer and BioNTech begin clinical trial of Omicron-based vaccine, timeline to authorization is unclear ( STAT ) ( BioPharma Dive ) Fauci says 'prudent' to have Omicron vaccine, but may not be needed ( Reuters ) J&J expects COVID vaccine sales to jump...
  • Regulatory NewsRegulatory News

    FDA outlines rules for ‘portions’ of official samples in draft Q&A guidance

    The US Food and Drug Administration (FDA) on Friday issued a draft guidance in a question-and-answer format clarifying the regulatory requirements for collecting and providing portions of official samples of drugs, foods or cosmetics under section 702(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).   The 12-page draft guidance contains 10 questions and answers providing an overview of FDA’s interpretation of its regulations governing the collection and p...
  • Regulatory NewsRegulatory News

    Trulicity Instagram post draws OPDP’s first untitled letter of 2022

    In an untitled letter dated 19 January 2022, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) cites drugmaker Eli Lilly for a social media post about its type 2 diabetes mellitus drug Trulicity (dulaglutide).   According to the untitled letter, an Instagram post with a video component promoting Trulicity failed to adequately present the drug’s FDA-approved indication and limitations of use. It also failed to include “material i...
  • ReconRecon

    Recon: FDA rejects Merck’s chronic cough drug, Pfizer-OPKO growth hormone deficiency treatment; EMA expected to decide on Pfizer COVID pill by end of January

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Califf on Path to Win FDA Chief Role Despite Expected ‘No’ Votes ( Bloomberg ) FDA approves use of antiviral drug remdesivir as an outpatient therapy for people with covid-19 ( Washington Post ) ( BioPharma Dive ) Merck drug for chronic cough rejected by FDA ( BioPharma Dive ) ( Reuters ) ( Endpoints ) FDA expected to sharply restrict use of two monoclonal ant...
  • Regulatory NewsRegulatory News

    CDRH outlines plan to understand sex and gender differences in medical devices

    The US Food and Drug Administration (FDA) has finalized its strategic plan for incorporating sex and gender differences into the development and regulation of medical devices. The Health of Women Program Strategic Plan , released on 18 January 2022, outlines priorities for integrating the health of women into the research and regulatory work of FDA’s Center for Devices and Radiological Health (CDRH). The strategic plan finalizes a proposal released in September 2019. ...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    As the COVID-19 pandemic wears on, a handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely. Among those treatments are dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/Ro...
  • Regulatory NewsRegulatory News

    This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we look at some newly published data from FDA on its user fee program performance, REMS programs and generic drug approvals.   A new FDA guidance on diversity plans to improve the enrollment of underrepresented racial and ethnic groups in clinical trials may see the light o...
  • Regulatory NewsRegulatory News

    European Parliament endorses legislation bolstering EU’s ability to tackle shortages

    The European Parliament approved legislation to increase the powers of the European Medicines Agency (EMA) in monitoring and responding to drug and device shortages.   The measure advanced by a 655-31 vote, with eight abstentions. The legislation is based on an agreement reached last October between Parliament and the European Council on changes intended to improve the management of future health crises and shortages of drugs and medical devices. (RELATED: EU Par...
  • ReconRecon

    Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device shortage list

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US preparing for possible future COVID variants -White House ( Reuters ) The scientists, they’re learning more’: A defiant Biden defends the CDC amid mounting criticism ( STAT ) Avastin Withdrawal Showed Accelerated Approval Hearing Process No Easy Task For US FDA ( Pink Sheet ) FDA adds all blood sample collection tubes to medical device shortage list ( Reute...
  • Regulatory NewsRegulatory News

    FDA offers examples of innovative study designs accepted into CID pilot

    The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex Innovative Trial Designs (CID) pilot meeting program.   The aim of presenting the case studies is to help sponsors understand factors that should be considered when proposing a CID. The pilot program was launched in 2018 to accelerate the development of therapies for unmet med...