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    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...
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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...
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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...
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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 ...
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    ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

    A recently released survey from the International Council on Harmonisation (ICH) shows pharmaceutical regulators and companies around the world are adopting and adhering to the council’s guidelines related to quality, safety and efficacy. The survey of 32 pharmaceutical companies provided responses on 15 regulatory authorities, which included the founding ICH members: the European Medicines Agency, the US Food and Drug Administration, Japan’s MHLW/PMDA, Health Canada an...
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    Experts Pitch FDA on Policies to Improve Drug Development

    The US Food and Drug Administration (FDA) on Thursday heard from more than two dozen stakeholders on opportunities for the agency to promote more effective drug development programs at a public workshop at its headquarters in Silver Spring, Maryland.   “Effective drug development programs leverage the best available scientific knowledge to characterize the benefits and risks of a potential product and generate the data necessary to support product approval,” FDA says, ...
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    FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade

    The US Food and Drug Administration (FDA) said Thursday that it has decided to revoke the orphan designation granted to Indivior’s opioid use disorder (OUD) treatment Sublocade (buprenorphine extended-release injection). Approved as a sublingual tablet in 2002 and known as Subutex (buprenorphine), the drug received orphan designation and seven years of exclusivity thorough 2009. In 2017, FDA approved Indivior’s extended release injection of buprenorphine, known as Sublo...