• Regulatory NewsRegulatory News

    EMA Draft Guidance Seeks to Speed New Antibiotics Development

    The European Medicines Agency (EMA) is seeking comment on a new draft guideline that could help industry use of pharmacokinetics (PK) and pharmacodynamics (PD) analyses to speed the development of novel antibiotics that target multidrug-resistant bacteria and address unmet medical needs. Background Like in the US, the growth of bacteria resistant to a range of antibiotics, along with the need for new antibiotics to treat patients with limited or no treatment options, sp...
  • FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing

    The US Food and Drug Administration (FDA) has unveiled a new guidance document on biosimilars, this time explaining how to use clinical pharmacology data to show similarity to a reference product. Background The guidance, Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product , is one of several under development by FDA to establish a thorough biosimilar pathway. While the Patient Protection and Affordable Care Act (PPACA) ves...
  • GHTF Proposes New Harmonization of Medical Device Audits

    The Global Harmonization Task Force ( GHTF ), a medical device-focused regulatory harmonization organization which counts among its members many of the world's top regulatory agencies, announced a new proposed medical device standard aimed at introducing a grading system to be used during regulatory audits by regulatory authorities and auditing organizations. The proposed document, SG3(PD)/N19: Quality Management System - Medical Devices - Nonconformity Grading System ...
  • Feature ArticlesFeature Articles

    Biosimilars Breaching Borders: How FDA and EMA Find Common Ground

    Human clinical pharmacology, pharmacokinetic (PK) and pharmacodynamic (PD) studies are vital for many reasons, and uniquely useful in extrapolating the efficacy and safety of biosimilars. PK and PD studies are the most objective clinical trials, and are sensitive to changes in a drug product. But the workings and concepts behind such studies are not well understood by many in industry, and even physicians, in comparison with clinical efficacy. This article presents a E...