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  • ReconRecon

    Recon: Novo Nordisk to buy Dicerna for $3.3B; US signs deal for $5.3B worth of Pfizer's COVID antiviral drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer ( BioPharmaDive ) ( FDA ) Pfizer signs $5.3 billion U.S. deal to supply COVID-19 antiviral pills ( Reuters ) J&J sees potential for 14 new multibillion-dollar drugs by 2025 ( Reuters ) White House Plans Major Expansion of Covid Vaccine Production ( NYTimes ) Gilead pays up to retain ...
  • Regulatory NewsRegulatory News

    FDA urged to endorse EPCIS to spur manufacturers' uptake of DSCSA

    The pharmaceutical industry and other trading partners told the US Food and Drug Administration (FDA) to endorse the use of Electronic Product Code Information Services (EPCIS) for tracing products through the supply chain by finalizing its guidance on standards for the interoperable exchange of product information.   Doing so would help improve industry’s uptake of exchanging product data well ahead of the November 2023 deadline when these systems go live, say trading...
  • RoundupsRoundups

    FDA Approvals Roundup: Besremi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Besremi okayed for rare blood disease PharmaEssentia’s Besremi (ropeginterferon alfa-2b-njft injection) has been approved for treating adults with polycythemia vera, a blood disease caused by a JAK2V617F mutation that results in overproduction of red blood cells (RBCs).   The monopegylated, long-acting interferon alfa-2b reduces excess RBCs...
  • ReconRecon

    Recon: Biogen's Alzheimer's drug gets negative trend vote from EMA panel; EMA says Novavax authorization could come 'within weeks'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Plans to Authorize Pfizer Boosters for All Adults This Week ( NYTimes ) Watchdog group calls on FDA to disqualify Hennepin Healthcare doctors, review board from clinical research ( StarTribune ) U.S. plans to invest billions in manufacturing COVID-19 vaccine ( Reuters ) ( Politico ) Pfizer CFO D'Amelio to retire after 15 years at company ( Reuters ) U.S. ...
  • Regulatory NewsRegulatory News

    FDA inspection turns up more problems for Philips Respironics

    Hundreds of thousands of complaints from users of Philips Respironics’ breathing assistance devices have been inadequately addressed by the firm, according to recent information released by the US Food and Drug Administration (FDA). The release of an inspection report and FDA’s accompanying statement provides more detail on what Philips knew, and what the firm did – or did not do – to remedy known problems with degradation of foam components in its breathing devices.   ...
  • Regulatory NewsRegulatory News

    CHMP recommends 11 new medicines for authorization, including two COVID-19 monoclonal antibodies

    The European Medicine Agency’s (EMA) Committee for Medicinal Products (CHMP)   last week recommended 11 new medicines for approval in the EU, including Europe’s first two new monoclonal antibodies for treating COVID-19. The agency also recommended the rejection of a treatment for neovascular (wet) age-related macular degeneration.   CHMP recommended authorizing Celltrion Healthcare Hungary’s Regkirona (regdanvimab) and Roche’s Ronapreve (casirivimab/imdevimab) for tre...
  • Regulatory NewsRegulatory News

    Long-awaited Cures 2.0 bill unveiled

    Two years after beginning work on a follow up to the 21 st Century Cures Act , Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday introduced their Cures 2.0 bill.   The 173-page bill, intended to supercharge medical innovation, would provide new funding for programs at the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid services (CMS), as well as create the $6.5 billion Advanced Research Projects Agency for Health (ARPA-H). A co...
  • Regulatory NewsRegulatory News

    Asia-Pacific Roundup: TGA posts guidance on transition to device reclassification after consultation confusion

    Australia’s Therapeutic Goods Administration (TGA) has published guidance on the transitional arrangements for the reclassification of certain medical devices. The guidance follows a consultation that exposed the urgent need for clarification of the classification rule and definitions.   TGA’s guidance applies to medical devices that are substances introduced into the human body via a body orifice or applied to the skin. As TGA explains in the document, that definition...
  • ReconRecon

    Recon: Pfizer to allow generic versions of its COVID drug in 95 countries; Moderna, EU sign deal to donate 70M vaccine doses

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer asks FDA to authorize COVID-19 pill for unvaccinated people ( NYTimes ) As Big Pharma and Hospitals Battle Over Drug Discounts, Patients Miss Out on Millions in Benefits ( KHN ) Report says drugmakers impose unjustified U.S. price increases; spending on AbbVie drug rises $1.4 billion ( Reuters ) ( BioPharmaDive ) ( Fierce ) Pharmacy chains defend action...
  • Regulatory NewsRegulatory News

    FDA officials address common pitfalls affecting post-approval change applications

    The US Food and Drug Administration (FDA) offered some advice to help ensure smoother reviews of abbreviated new drug application (ANDA) post-approval supplements and addressed how certain changes should be categorized at the 10 November meeting of the Association for Accessible Medicines” (AAM) GRx+Biosim conference.   Officials were asked to address common issues affecting ANDA post-approval chemistry, manufacturing and controls (CMC) submissions. Agency officials ...
  • Regulatory NewsRegulatory News

    FDA revises COVID test approach after HHS reverses Trump-era LDT directive

    The US Food and Drug Administration (FDA) on Monday revised its guidance on COVID-19 tests during the public health emergency after the Department of Health and Human Services (HHS) withdrew a Trump-era policy that restricted FDA from requiring premarket review for laboratory developed tests (LDTs).   Under the updated policy, FDA said it generally expects that newly offered COVID-19 tests will have an emergency use authorization (EUA) or traditional marketing authoriz...
  • Regulatory NewsRegulatory News

    FDA could do more to enforce ClinicalTrials.gov reporting requirements

    The US Food and Drug Administration (FDA) hasn’t been notifying most clinical trial sponsors they are in violation of reporting requirements.   That’s according to results of a Freedom of Information Act (FOIA) investigation by Reshma Ramachandran, of the Yale School of Medicine in New Haven, CT, and colleagues in a recent Viewpoint published in JAMA .   In January 2017, a final rule issued by the National Institutes of Health (NIH) determining ClinicalTrials.go...