• Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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, ...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: FDA Panel Warns No Adequate Replacement for Ethylene Oxide; Cardinal Health Wins $2.25B DoD Medical Supplies Contract

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Ethylene oxide plant closures put US on 'cusp of a major medical logistical failure' ( MedtechDive ) AdvaMed Statement on EtO Air Testing by EPA ( AdvaMed ) ( EPA v) Sarepta Therapeutics CEO playing nice with FDA over rejection of Duchenne drug ( STAT ) ( Fierce ) House Speaker Nancy Pelosi pushes vote on sweeping drug-pricing bill to December ( CNBC ) Senate...
  • Regulatory NewsRegulatory News

    EC Extends Deadline for Experts to Apply for MDR/IVDR Panels

    The European Commission (EC) said Thursday that it has extended the deadline by almost two weeks for experts to apply to be a part of panels that will evaluate high-risk medical devices and in vitro diagnostics (IVDs) under the incoming Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The new deadline is 24 November. As first discussed in September, panel experts are expected to be objective (EC says they must have no financial or other in...
  • Regulatory NewsRegulatory News

    Danish Medicines Agency Revokes Scanpharm’s Authorization to Manufacture Drugs

    Following an inspection that uncovered GMP deficiencies, the Danish Medicines Agency said Thursday that it has revoked Danish pharmaceutical company Scanpharm A/S’s authorization to manufacture medicinal products and intermediate products. A three-day inspection in September showed the company lacked the necessary knowledge regarding its responsibilities related to qualified persons, as well as other issues with reporting of out-of-specification (OOS) results, OOS and m...