• Regulatory NewsRegulatory News

    FDA’s Project Orbis May Expand to Singapore and Switzerland

    The US Food and Drug Administration (FDA) may expand a pilot project that allows for simultaneous drug approval decisions from US, Canadian and Australian regulators to include Singapore and Switzerland, Richard Pazdur, director of FDA’s Oncology Center of Excellence, said Tuesday at the Friends of Cancer Research's annual meeting in Washington, DC. If Singapore and Switzerland are added, Pazdur said following visits to both countries, it would further collaborations bet...
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    EMA Officials: Regulatory, HTA Advice Sped Access to Bluebird’s Gene Therapy

    Officials from the European Medicines Agency (EMA) say that advice from the agency and health technology assessment (HTA) bodies played a “key role” in speeding access to Bluebird Bio’s gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene).   “Groundbreaking therapies such as Zynteglo present specific challenges for those who assess their benefits and risks for the initial authorisation and those who assess their value as a basis for pricing and r...
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    EC Offers Further Clarity on Clinical Trial Regulation

    The European Commission (EC) recently updated guidance on the incoming clinical trials regulation, with new questions and answers (Q&As) on requests for information (RFIs), how assessment reports will be made public and the sponsor’s responsibilities regarding changes to a clinical trial that are not substantial modifications but are relevant for supervising the trial. On the question (number 2.7) of the management of a request for information during the initial assessm...
  • ReconRecon

    Recon: Solid Biosciences Gene Therapy Study Put on Hold Again; Lonza CEO to Depart After Less Than a Year

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Google’s ‘Project Nightingale’ Gathers Personal Health Data on Millions of Americans ( WSJ ) ( Reuters ) ( NYTimes ) ( CNBC ) Shares of Amarin jump after FDA staff review on fish-oil drug ( Reuters ) ( STAT ) ( Endpoints ) Solid Biosciences gene therapy trial put on hold for second time, shares slump ( Reuters ) ( STAT ) It’s tiny biotechs — not big drug maker...
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    FDA Warns Mylan’s Indian API Facility Over Contamination Concerns

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last week to Mylan’s active pharmaceutical ingredient (API) manufacturing site in Andhra Pradesh, India, highlighting “contamination at levels above the limit” for some API batches. FDA’s inspection of the site in May and June uncovered, “Multiple contract manufacturers supplied solvents that were contaminated with [redacted], but your firm lacked documentation of which tanks were used t...
  • RoundupsRoundups

    Asia Regulatory Roundup: Industry Questions TGA’s Ability to Enforce Proposed Software Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Medtech Industry Questions TGA’s Ability to Enforce Proposed Software Rules   The medtech industry has questioned whether the Therapeutic Goods Administration (TGA) can ensure all Software as a Medical Device (SaMD) products are included in the Australian Register of Therapeutic Goods (ARTG).   TGA proposed mandating the inclusion of SaMD products in the ARTG when ...
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    France to Maintain Fast Track Schemes for Clinical Trials

    As the new EU clinical trial regulation is expected to take effect next spring, France’s drug regulator, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), said it will maintain two fast tracks to speed clinical trials for new and already known medicinal products. The two fast track processes, which were established last year and then extended to advanced therapy medicinal products (ATMPs) in February, allow for innovative drug trial applicati...
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    IMDRF Offers Three Final Clinical Guidelines

    The International Medical Device Regulators Forum (IMDRF) recently released three final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices, replacing earlier versions of the documents developed by the Global Harmonization Task Force (GHTF).   Clinical Evaluations   In the 30-page document on clinical evaluations , IMDRF defines a clinical evaluation as “a set of ongoing activities that use scientifically sound meth...
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    Regenxbio Sues FDA Over Unexplained Clinical Trial Hold

    Biotech company Regenexbio sued the US Food and Drug Administration (FDA) last week for failing to provide an explanation for placing a hold on a clinical trial for an experimental gene therapy to treat wet age-related macular degeneration. FDA’s decision effectively halted the development of the potential one-time subretinal treatment without a clear basis, the complaint said. “By failing to provide advance notice of, or any reasoned basis for, the clinical hold, FD...
  • ReconRecon

    Recon: FDA Rejects Lipocine Testosterone Drug for the Third Time; Roche SMA Drug Hits Goal in Pivotal Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democratic presidential hopefuls want to take on pharma. Here’s how they’d do it ( STAT ) Voters Say Congress Needs to Curb Drug Prices, But Are Lawmakers Listening? ( KHN ) Celgene's drug for anemia in beta thalassemia priced at $3,441/ 25 mg vial ( Reuters ) ( Endpoints ) ( FDA ) FDA rejects Lipocine's testosterone drug for third time ( Reuters ) ( Endpoints...
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    Orphan Drug Recall Leaves Patients in the Lurch

    When Brenda Shelton, a hair stylist in Las Vegas, logged into a private Facebook group in September, she did not expect to find out about a recall of an injectable drug she takes to control her hypoparathyroidism, a rare disorder with potentially deadly complications. And since Takeda’s Natpara (parathyroid hormone) injection is the only effective treatment for Shelton, she knew when she received an official Takeda recall letter via UPS four days later that difficulties...
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    WHO Commends Russian Response to Proposed Heritable Human Genome Editing

    Following the birth of the world’s first genome-edited babies in November 2018, the World Health Organization’s (WHO) Expert Advisory Committee on Human Genome Editing was established a month later to further understand and regulate human genome editing in both somatic cells and cells of the germline, including early embryos. Since its establishment, Denis Rebrikov, chief geneticist at Russia’s largest government-run in vitro fertilization clinic, sought to genetically ...