• Regulatory NewsRegulatory News

    Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants

    Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Administration (FDA) audit published in the International Journal of Pharmaceuticals .   Authors from the FDA Center for Drug Evaluation and Research (CDER) said these manufacturers had a potential estimated increase in revenue due to the ...
  • Regulatory NewsRegulatory News

    European Commission adopts common specifications for high-risk IVDs

    The European Commission on Monday issued a regulation that establishes common specifications certain high-risk in vitro diagnostics (IVD), which are a critical component of the In Vitro Diagnostic Regulation (IVDR).   The Commission explains that harmonized standards do not exist for certain class D IVDs, “and there is a need to address public health concerns as the risk associated with the use of those devices is significant for public health and patient safety.” ...
  • Regulatory NewsRegulatory News

    Health policy experts call for stronger accelerated approval reforms

    The US Congress should take concerns raised by the Food and Drug Administration (FDA) seriously and give the agency more authority around accelerated approvals, including the power to expedite the withdrawal of drugs from the market, according to a perspective article from three experts on drug regulation and health policy.   The perspective, written by Rachel E. Sachs, JD, MPH, of Washington University in St. Louis, Julie M. Donohue, PhD, of the University of Pittsbur...
  • ReconRecon

    Recon: FDA grants priority review for Biogen-Eisai’s Alzheimer’s drug; Senate Democrats advance drug-price deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA decision on Eisai, Biogen Alzheimer's drug due in January ( Reuters ) ( Fierce ) ( The Pink Sheet ) ( Bloomberg ) NBC pundit, public health expert Vin Gupta in line for top Biden administration spot ( Politico ) Roche’s Lunsumio eyes year-end FDA verdict to be first bispecific for non-Hodgkin lymphoma ( Fierce )  ( Pharmaphorum ) Coherus, Junshi’s Cancer C...
  • Regulatory NewsRegulatory News

    FDA publishes two critical DSCSA draft guidances

    The US Food and Drug Administration (FDA) on 5 July issued two draft guidances covering the implementation of the Drug Supply Chain Security Act (DSCSA); one addresses the use of electronic standards for tracing products through the pharmaceutical supply chain, while the other guidance pertains to identifying trading partners that are authorized to track products though the supply chain.   The agency announced that “these documents are critical steps toward implement...
  • ReconRecon

    Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA to convene second panel of outside experts to review Amylyx Pharma’s ALS treatment ( STAT ) ( Endpoints ) ( Reuters ) Novavax expects COVID vaccine targeting Omicron in fourth quarter ( Reuters ) Can Biogen’s backup plan for Alzheimer’s succeed? ( Boston Globe ) Another Duchenne clinical hold gets lifted, this time at Dyne Therapeutics ( Endpoints ) FDA C...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA updates uniform recall procedure

    Two key changes highlight the updated version 2.3 of the uniform recall procedure from Australia’s Therapeutic Goods Administration (TGA) – the removal of a section on crisis management guidelines and the addition of details on what the agency expects to receive in relation to recalls.   Deletion of the section on crisis management guidelines is notable. In version 2.2, TGA urged sponsors to implement the guidelines “as quickly as possible and ensure that appropriate p...
  • This Week at FDAThis Week at FDA

    This Week at FDA: User fee timeline, bivalent boosters, and more

    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. The biggest news out of FDA this week was the agency’s decision to recommend the inclusion of an Omicron BA.4/5 component in future booster doses in the first shift in strain composition away from monovalent vaccines targeting the prototype virus.   Alongside the recommendation, FD...
  • Regulatory NewsRegulatory News

    FDA tells Dutch API producer to clean up its equipment act

    A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Administration (FDA) dated 14 June. FDA found the presence of “visible powder residue” on non-dedicated equipment.   The warning letter pertained to Fagron Group B.V.’s manufacturing site in Saint Paul, MN. The company is headquartered in ...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely.   As of July 2022, those treatments include 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/RoActemra (tocil...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

    Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...
  • Feature ArticlesFeature Articles

    Supply chain disruptions: FDA guidance and temporary policies

    The COVID-19 pandemic caused one of the most prominent displays of supply chain disruption in the modern era. However, the US Food and Drug Administration (FDA) found ways to allow for regulatory flexibility by issuing guidance documents while still managing to protect consumers from adulterated and misbranded food.   Keywords – COVID-19 , FDA, food, guidance, pandemic, supply chain   Introduction The complexity of modern supply chains is never more eviden...