• Regulatory NewsRegulatory News

    EMA shares lessons learned from biosimilars pilot

    The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Agency (EMA) to provide scientific advice to sponsors on their biosimilar development programs, according to a report on the agency’s recently concluded biosimilar scientific advice pilot.   Also, EMA found that current regulatory guidelines, which assume that developers will take a stepwise approach to biosimilar development where clinical studies are condu...
  • Regulatory NewsRegulatory News

    FDA says IRB review still needed for IVD studies involving human specimens

    The US Food and Drug Administration (FDA) reiterates that clinical studies of in vitro diagnostic devices (IVDs) using leftover, "deidentified" human specimens still have to be approved by Institutional Review Boards (IRBs).   This pronouncement was made in an 18 October reminder letter to IVD manufacturers by William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality within FDA’s Center for Devices and Radiological Health. ...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA moves to make patient information rules more flexible after consultation

    Australia’s Therapeutic Goods Administration (TGA) is set to allow more flexibility in how medical device patient information materials are provided after holding a consultation into possible reforms.   TGA has been phasing in requirements for sponsors of implantable medical devices to provide patient information leaflets (PIL) and patient implant cards (PIC) since late 2018. The experience has triggered feedback from consumers, healthcare professionals, surgeons, hosp...
  • ReconRecon

    Recon: WHO aims to buy Merck COVID drug for $10 per pill; CDC study finds Pfizer vaccine highly effective against hospitalization in 12-18 year olds

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA proposes over-the-counter hearing aids for Americans ( Reuters ) ( FDA ) Pfizer-BioNTech’s vaccine is highly effective against hospitalization for those 12 to 18, a study shows. ( NYTimes ) J&J keeps vaccine sales outlook unchanged after third-quarter miss ( Reuters ) FDA to Allow ‘Mix and Match’ Approach for Covid Booster Shots ( NYTimes ) ( Reuters ) At...
  • Regulatory NewsRegulatory News

    EC updates Clinical Trial Regulation Q&As ahead of January go-live

    The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January.   The revision clarifies that active pharmaceutical ingredients (APIs) used in investigational medical products do not have to comply with good manufacturing practices (GMPs) in the clinical trial application, describes the content of the protocol synopsis, and adds a new question o...
  • Regulatory NewsRegulatory News

    Cyltezo approved as interchangeable biosimilar with Humira

    An anti-inflammatory biosimilar from Boehringer-Ingelheim has received interchangeability designation from the US Food and Drug Administration (FDA).        Cyltezo (adalimumab-adbm) is now both biosimilar to and interchangeable with Abbvie’s Humira (adalimumab), announced FDA, which had granted biosimilar status to Cyltezo in 2017. Cyltezo is approved for all indications for which Humira can be used, including several inflammatory arthritides, Crohn’s disease and ulce...
  • ReconRecon

    Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young children

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA considering lowering recommended age for Pfizer/BioNTech COVID-19 boosters ( Reuters ) FDA delays decision on Moderna's COVID-19 vaccine for adolescents ( WSJ ) ( Reuters ) FDA declines to approve Revance's frown-line treatment ( Reuters ) ( Endpoints ) Oyster Point's drug becomes first FDA-approved nasal spray to treat dry eyes ( Reuters ) ( Endpoints ) ...
  • Regulatory NewsRegulatory News

    FDA officials tout progress and achievements in advanced manufacturing

    The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturing is bearing fruit, according to a new update from the agency, noting robust interest from industry in participating in the agency’s Emerging Technologies Program (ETP).   In addition, “significant funding” from Congress has helped fund more research in advanced manufacturing, wrote Michael Kopcha, director of the Office of Pharmaceutical Quality in the FD...
  • Regulatory NewsRegulatory News

    FDA adcomm unanimous on J&J boosters for all

    The vaccines advisory committee of the US Food and Drug Administration (FDA) voted unanimously Friday to recommend a full-strength booster dose of the COVID-19 vaccine made by Janssen, the vaccines arm of Johnson & Johnson, for all recipients of the single-dose primary vaccination.   The Vaccines and Related Biologic Products advisory committee (VRBPAC) recommended that FDA issue an emergency use authorization (EUA) for a booster to be given at least 2 months after the...
  • Regulatory NewsRegulatory News

    CHMP recommends 6 medicines for authorization, Incyte pulls application for Zynyz

    The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) this week recommended six new medicines for marketing authorization in the EU.   The recommendations include positive opinions for four medicines and one generic, as well as conditional authorization for Janssen's Rybrevant (amivantamab) for the treatment of non-small cell lung cancer with activating epidermal growth factor receptor exon 20 insertion mutations.   The recomme...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost two dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that are au...
  • ReconRecon

    Recon: Bayer, CureVac end vaccine production partnership; FDA calls advisory committee to discuss Merck's COVID drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA advisers to vote on J&J vaccine booster ( Reuters ) FDA advisers back Moderna COVID booster shots for older and high-risk people ( Reuters ) ( NYTimes ) Abbott Labs unit recalling two COVID-19 lab test kits – FDA ( Reuters ) As suits mount, J&J spins out talc liabilities into Chapter 11 using 'Texas two-step' maneuver ( Endpoints ) ( FT ) FDA to Hold...