• Regulatory NewsRegulatory News

    EC issues first COVID therapeutics portfolio

    As part of its strategy for COVID-19 therapeutics, the European Commission (EC) on Tuesday released a portfolio of the initial five therapeutics being considered for authorization for the treatment of COVID-19 patients.   Four of the candidate therapeutics are monoclonal antibodies in consideration under the European Medicines Agency’s rolling review process. The fifth therapeutic being considered, Eli Lilly’s Olumiant (baricitinib), is an orally administered immunosup...
  • Regulatory NewsRegulatory News

    FDA warns Lupin subsidiary, aesthetics firm

    The US Food and Drug Administration (FDA) sent warning letters to generic drugmaker Lupin, Inc. over good manufacturing practice (GMP) issues at one of its US-based subsidiaries’ facilities and medical aesthetics firm Aquavit Pharmaceuticals for marketing two devices without approved applications.   Novel Laboratories, Inc.   In its 11 June warning letter to Lupin subsidiary Novel Laboratories, Inc., FDA cites the firm for three GMP violations at its Somerset, New ...
  • Regulatory NewsRegulatory News

    Asia-Pacific Roundup: China outlines vision for national vaccine QMS

    China’s National Medical Products Administration (NMPA) has shared plans for the next steps in the development of its vaccine regulatory quality management system. NMPA is calling on affiliated and provincial institutions to establish and connect their vaccine regulatory quality management systems to the national resource to create a unified network.   The Chinese regulator committed to overhauling the regulation of the vaccine supply chain in 2016 in response to a s...
  • Regulatory NewsRegulatory News

    EMA gives procedural guidance on variant COVID vaccines

    A new document from the European Medicines Agency (EMA) will give vaccine developers procedural guidance when the time comes for them to update COVID-19 vaccines to include protection against variant strains of SARS-CoV-2.   The procedural guidance was adopted by EMA’s human medicines committee on 24 June, and is meant to apply to vaccines against other human coronaviruses as well. Marketing authorization holders may submit a variation to change the composition of a CO...
  • Regulatory NewsRegulatory News

    MDCG outlines Eudamed obligations for legacy, custom devices

    The European Commission’s Medical Device Coordination Group (MDCG) last week released a questions and answers guidance detailing how Eudamed rules apply to actors not subject to registration requirements under the medical devices regulation (MDR) and in vitro diagnostic regulation (IVDR), including manufacturers of custom-made and legacy devices.   The guidance also clarifies situations in which an Actor ID is issued instead of a single registration number (SRN). An ...
  • Regulatory NewsRegulatory News

    FDA releases new draft guidance on sponsor role for safety reporting requirements

    The US Food and Drug Administration (FDA) has released a new draft guidance for sponsors on safety reporting requirements and assessments for investigational new drug application (IND) and bioavailability/bioequivalence (BA/BE) studies.   In a notice announcing the availability of the draft guidance, FDA said this latest version iterates on the “Safety Assessment for IND Safety Reporting” draft guidance released in 2015, and “provides recommendations related to the two...
  • Regulatory NewsRegulatory News

    House subcommittee proposes $257M increase for FDA in FY2022

    The US Food and Drug Administration (FDA) would see a $257 million increase in its budget authority for FY2022 under a draft funding bill that advanced to the House Appropriations Committee on Friday.   The draft legislation was released late on Thursday ahead of the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies’ markup of the bill the following morning.   While the bill would provide FDA with $86 million less th...
  • Regulatory NewsRegulatory News

    CHMP recommends eight new medicines, including first CAR-T for multiple myeloma

    At its June meeting, the European Medicine Agency’s (EMA) human medicines committee recommended eight new medicines for approval, including Europe’s first chimeric antigen receptor T-cell therapy for multiple myeloma, two orphan drugs, three non-orphan medicines and two generic drugs.   The Committee for Medicinal Products for Human Use (CHMP) also issued one negative opinion and recommended extending the therapeutic indications of six other medicines.   The commit...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • 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 ...