• Regulatory NewsRegulatory News

    EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper

    The European Medicines Agency (EMA) on Thursday opened a public consultation on the International Council for Harmonisation’s (ICH) S12 guideline on nonclinical biodistribution (BD) considerations for gene therapies.   The S12 guideline recently reached Step 2b of the ICH process after being endorsed at the ICH Assembly virtual meeting earlier this month. (RELATED: ICH reports ‘significant milestones’ reached on guidelines ranging from impurity testing to eCTD standa...
  • Regulatory NewsRegulatory News

    FDA calls for inclusion of patients with incurable cancers in oncology trials

    Patients with incurable cancers should be included in clinical trials for investigational cancer therapies, regardless of whether they have received available treatments, the US Food and Drug Administration (FDA) recommends in a draft guidance released Thursday.   “The FDA believes patients with incurable cancers, if provided adequate information to make an informed decision, should be eligible to participate in oncology clinical trials. If there is no scientific ratio...
  • Feature ArticlesFeature Articles

    Enhancing consumer confidence and supplement access through harmonized retail standards

    Although third-party audit, certification, and retail standard programs highlight reputable companies and help ensure that dietary supplements on store shelves are safe and unadulterated, multiple standards create a complicated patchwork of requirements that are difficult for manufacturers and consumers to navigate. Responsible industry has emphasized the need to harmonize standards by eliminating duplicative, costly testing and allowing retailers to confirm a manufacturer...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost 20 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 vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in early de...
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    FDA’s OGD hears ways to accelerate complex generic development

    Pharmaceutical industry officials speaking at a Wednesday workshop on complex generics suggested that the US Food and Drug Administration (FDA) create alternative pathways for assessing bioequivalence for some of these products and provide more guidance on assessing the bioequivalence of metered-dose inhalers.   A series of industry officials spoke at a 23 June public workshop on ways the agency could accelerate the development of complex generics. The agency is requir...
  • RoundupsRoundups

    Euro Roundup: European Council, Parliament reach informal deal on contentious HTA regulation

    The European Council and Parliament have reached an informal deal on a planned health technology assessment (HTA) law. European Union officials are working on the HTA law to support cross-border cooperation on the clinical assessment of health technologies.   Full details of the compromise are yet to emerge, but the agreement has already come under attack. Pharma trade group EFPIA said, “The failure to agree on a predictable, efficient and non-duplicative system is a m...
  • ReconRecon

    Recon: Lilly to seek accelerated approval for its Alzheimer’s drug; FDA to add warning about rare heart inflammation to Pfizer, Moderna vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen working to speed up confirmatory study for approved Alzheimer's drug ( Reuters ) Biogen opens door to adjusting price of Alzheimer's drug amid outcry ( The Hill ) Lilly to seek accelerated FDA approval for Alzheimer's drug this year ( Reuters ) ( STAT ) ( Press ) Op-Ed: Here’s why we approved the 1st new Alzheimer’s drug in 2 decades ( WaPo ) ( STAT ) ...
  • Regulatory NewsRegulatory News

    Cures 2.0: Discussion draft signals impact on FDA, creation of ARPA-H

    More than four years after the 21 st Century Cures Act was signed into law, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on Tuesday circulated a discussion draft of their proposed Cures 2.0 legislation, setting the stage for negotiations on the long-awaited legislative package.   In addition to proposing new programs and enhancements for the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), the 127-page draft bill ...
  • Regulatory NewsRegulatory News

    Shuren: Time to rethink FDA's device regulatory framework

    Rethinking the medical device regulatory framework has been on the mind of Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA), especially in light of lessons the agency learned during the COVID-19 pandemic.   When he became director at CDRH in 2009, Shuren said, the medical device industry was in a different place. “Innovators were bringing their technologies overseas, first due to incr...
  • ReconRecon

    Recon: WHO cites concerns about Sputnik V plant; GSK’s drug arm to get $11B windfall from consumer spin-off

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA documents show struggle over approval of new Alzheimer's drug from Biogen ( Reuters ) ( WSJ ) ( Boston Globe ) ( STAT ) ( Politico ) Woodcock defends Biogen's new Alzheimer's drug, says it has more supportive data than many past accelerated approvals ( Endpoints ) Powerful Democrat’s new drug pricing manifesto hints at a carveout for small biotechs ( STAT )...
  • RoundupsRoundups

    FDA Approvals Roundup: Pradaxa, Ayvakit, Astepro

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Pradaxa gets new indication as oral therapy for VTE in children Boehringer Ingelheim’s Pradaxa (dabigatran etexilate oral pellets) has received an expanded indication for treating venous thromboembolism (VTE) in children aged 3 months to younger than 12 years after they have received blood thinner by injection for at least five days. The oral ...
  • Regulatory NewsRegulatory News

    Include cancer patients in COVID-19 vaccine trials, say ASCO and Friends of Cancer Research

    People with cancer should be included in COVID-19 vaccine clinical trials, according to a new joint position statement from the American Society of Clinical Oncology (ASCO) and the Friends of Cancer Research (FCR).   “We’ve learned that patients with cancer are especially vulnerable to severe illness, hospitalization, or death due to COVID-19,” said ASCO President Everett E. Vokes in a joint press release announcing the position statement. “It is critically important...