• Regulatory NewsRegulatory News

    Euro Convergence: Early consultation critical in overcoming gene therapy hurdles

    When it comes to advancing gene therapy products in the United States and Europe, the key is early consultation with regulators and identification of potential problems, experts said at the Euro Convergence 2020 virtual meeting. “It is better to do it earlier and establish a collaborative and educational approach to discussions,” advised Mridula Shukla, director of global regulatory affairs at Arcutis Biotherapeutics in Palo Alto, Calif.   Patrick Celis, PhD, head of ...
  • Euro Convergence: Navigating changing regulation of drug-device combination products

    As European regulators prepare to implement new requirements for drug-device combination products under the upcoming Medical Device Regulation (MDR), manufacturers and notified bodies are grappling with some of the lingering questions. “There are still some gaps… and some areas where we’d like to see more certainty, but until then we will continue to keep the dialogue going,” Jonathan Sutch, PhD, senior medicinal specialist at the notified body BSI Group, said during a ...
  • Regulatory NewsRegulatory News

    EMA highlights multiple considerations when developing drugs for older adults

    In a recently released reflection paper, the European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may impact everything from the dosage form to the package labeling. But the sole focus should not be on chronological age since patients of any age may experience similar needs or impairments. “For example, the need for an easy to ...
  • Regulatory NewsRegulatory News

    IMDRF proposes update on postmarketing device studies

    The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies.   The update outlines when a PMCF study is indicated, the general principles of PMCF studies for medical devices, the design and implementation of studies, and the use of the clinical information. The document does not apply t...
  • Regulatory NewsRegulatory News

    FDA releases guidance documents on biocompatibility submissions and nitinol-containing devices

    The US Food and Drug Administration (FDA) has issued two new guidance documents related to premarket submissions on device biocompatibility with intact skin, as well as technical considerations for nitinol-containing devices.   In the draft guidance , issued 15 October, the FDA provided select updates on the type of compatibility information that should be included in premarket submissions for devices made from common polymers and fabrics that come in contact with int...
  • Regulatory NewsRegulatory News

    Testing requirements are likely slowing biosimilar entries in the US

    Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation of patent protections to brand-name drug rebates. Now a new analysis, published in the Mayo Clinic Proceedings , suggests that a “high testing bar” for biosimilars to gain regulatory approval is another contributing factor. The analysis found that the median time from the start of a Phase I study to approval by the US Food and Drug Administration (FDA) was more than 5 ye...
  • Regulatory NewsRegulatory News

    Good real-world outcomes for generic levothyroxine, despite narrow therapeutic index

    Generic versions of levothyroxine – a treatment for hypothyroidism -- are just as effective in restoring thyroid stimulating hormone levels as brand-name drugs in a real-world population, according to a recent study conducted by researchers from the US Food and Drug Administration, Yale University, and the Mayo Clinic.   Generic levothyroxine is prescribed about six-to-one over branded levothyroxine, but that still leaves generic prescriptions lagging behind prescrib...
  • Regulatory NewsRegulatory News

    FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs

    The US Food and Drug Administration (FDA) has updated its Frequently Asked Questions on the development and performance of diagnostics for SARS-CoV-2, which includes the agency’s plan to decline to review emergency use authorization (EUA) requests for laboratory developed tests (LDTs).   That decision follows an announcement from the US Department of Health and Human Services that LDTs would not be required to undergo premarket review.   FDA will continue to pr...
  • Regulatory NewsRegulatory News

    Report: FDA REMS program ineffective at curbing opioid misuse

    The US Food and Drug Administration (FDA) has been using the Risk Evaluation and Mitigation Strategies (REMS) program as a way to mitigate adverse events stemming from opioid misuse and abuse, but that program is a poor tool for fighting the opioid epidemic, the Health and Human Services Office of the Inspector General concluded in a new report .   The REMS program is a long-standing drug safety program that has allowed the FDA to require manufacturers to implement ...
  • Regulatory NewsRegulatory News

    FDA releases draft guidance for physiologically based PK analyses

    The US Food and Drug Administration (FDA) has issued draft guidance for industry on the use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications. A PBPK analysis uses models and simulations combining physiology, population, and drug substance and product characteristics to mechanistically describe the pharmacokinetic or pharmacodynamic behaviors of a particular drug product, according to the FDA. The idea behind using this techni...
  • Regulatory NewsRegulatory News

    Study calls for proactive surveillance of device AEs

    The US Food and Drug Administration (FDA) relies mainly on direct reports and regulator-initiated surveillance to flag safety concerns around medical devices, a system that may delay detection of adverse events (AEs), according to a new analysis published in JAMA Internal Medicine . “These data highlight the importance of proactive identification of postmarketing device-related safety issues to provide health care professionals with more complete data regarding potenti...
  • Regulatory NewsRegulatory News

    CONSORT-AI sets standards for reporting on artificial intelligence in trials

    A new consensus statement, dubbed the CONSORT-AI extension, lays out the rules of the road for clinical trial reports on interventions involving artificial intelligence (AI).   The statement, which was published in Nature Medicine and written by an international working group, includes 14 new items for researchers to routinely include in their manuscripts when reporting on AI interventions.   The statement calls on researchers who report on trials that include AI...