• Regulatory NewsRegulatory News

    Recent ruling gives FDA ammunition against unapproved cell therapies

    A recent appeals court decision strengthens the US Food and Drug Administration’s efforts to crack down on clinics making unapproved stem cell therapies, the agency’s Melissa J. Mendoza said at a recent meeting.   The 11 th US Circuit Court of Appeals rendered a decision in USA vs US Stem Cell Clinic LLC , agreeing with the “FDA that these products did not fit the same surgical procedure exemption” and should be regulated as drugs, said Mendoza, deputy director of ...
  • Regulatory NewsRegulatory News

    Regulatory science pilot floated in BsUFA III negotiations

    In the latest rounds of negotiations for the reauthorization of the Biosimilar User Fee Act (BsUFA III), industry and the US Food and Drug Administration (FDA) fine-tuned labeling and supplements language, sought to find new ways for developers to receive targeted feedback, and set the scope for future guidance documents.   In a series of three May 2021 meetings, the BsUFA III negotiation steering committee convened to work on these topics, and to hammer out an agreeme...
  • RoundupsRoundups

    Asia-Pacific Roundup: Rise in requests drives TGA to prioritize GMP clearances

    Australia’s Therapeutic Goods Administration (TGA) is prioritizing the assessment of good manufacturing practice (GMP) clearances over administrative changes because of an increase in the number of submissions it needs to process.   While TGA is seeing an increase in administrative change requests – manufacturer name changes, address revisions and the like – it has concurrently seen a greater rise in the volume of applications. To respond, the agency has deprioritized ...
  • ReconRecon

    Recon: AZ antibody cocktail fails to prevent COVID symptoms in large trial; Former FDA Commissioner Hahn ventures on to Flagship

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax says efficacy preserved in participants receiving influenza, COVID-19 vaccines ( Reuters ) Trump’s FDA commissioner takes job at Moderna backer ( Washington Post ) ( Endpoints ) Divisive Drug Patent Proposal From Trump Era Is on Biden Agenda ( Bloomberg ) ( Law360 ) Sage's depression drug study results show improvement in symptoms ( Reuters ) ( STAT ) ...
  • Feature ArticlesFeature Articles

    Best practices and education for probiotics amid regulatory uncertainty

    Nearly 3 years have passed since the US Food and Drug Administration (FDA) issued its draft guidance for industry on the labeling of probiotic quantity. During that time, consumer interest in probiotics has increased, product innovation has expanded, and the body of scientific research has grown – all with no final guidance or updates from the agency. With the growth of this category and continued regulatory uncertainty, responsible industry has stepped up with best practi...
  • Regulatory NewsRegulatory News

    FDA launches global Generic Drug Cluster

    In a new effort to boost alignment of scientific and regulatory approaches to generic drug development among global regulators, the US Food and Drug Administration is standing up a Generic Drug Cluster.   Described as “the first forum established for the world’s leading regulatory agencies to address generic drug development globally,” the new cluster, wrote FDA, is meant to help harmonize approaches global regulators take to generic drug development through a variety ...
  • Regulatory NewsRegulatory News

    ICH reports “significant milestones” reached on guidelines ranging from impurity testing to eCTD standards

    The International Council for Harmonisation (ICH) has reported that “significant milestones” were reached over the past year in the adoption of guidelines on residual solvent testing, carcinogenicity testing, and specifications for submitting applications in the electronic Common Technical Document (eCTD).   ICH made this 10 June announcement following a virtual meeting of the ICH Assembly. During the meeting, the ICH Assembly adopted several guidelines for Step 4 of t...
  • Regulatory NewsRegulatory News

    Brexit, COVID-19 headline EMA’s 2020 annual report

    The European Medicines Agency (EMA) started 2020 by wrapping up challenges associated with the UK’s decision to leave the EU, only to run headlong into additional challenges brought on by the COVID-19 pandemic. In the annual report that also marked the agency’s 25 th anniversary, EMA outlined a year that looked different than most.   “As the scientific body in charge of the regulation of medicines, EMA had an essential part to play in ensuring treatments and vaccines ...
  • ReconRecon

    Recon: Novavax COVID-19 vax 90%-plus effective; GSK pays big for Iteos' TIGIT-targeted immunotherapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine ( NYT ) ( NPR ) ( Reuters ) Another Sad Coronavirus Pandemic Milestone Is Approaching ( NPR ) U.S. Not On Pace To Meet Biden's Vaccination Goal ( NPR ) Eight states see rise in new COVID-19 infections ( The Hill ) U.S. has administered over 309 million doses of Covid-19 vaccines, CDC says ( CNBC ) How did ...
  • Regulatory NewsRegulatory News

    FDA panel split on approach to COVID-19 vaccines for younger children

    Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.   Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as th...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    More than a year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for a handful of treatments including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab; Regeneron’s casirivi...
  • Regulatory NewsRegulatory News

    Warning letter: FDA blasts Innova for falsifying data, GMP violations

    Editor's note: This article has been updated to include a statement from Innova. The US Food and Drug Administration issued a warning letter on 10 June to Innova Medical Group for distributing unauthorized SARS-CoV-2 rapid antigen tests and "false or misleading" information in the tests’ labeling.   The warning letter comes after FDA inspected two of the firm’s facilities in Pasadena and Brea, CA over the course of several weeks in March and April.   FDA also ...