• Regulatory NewsRegulatory News

    Updated: ICH Updates on MedDRA, New Members and Guidelines

    The International Council for Harmonisation (ICH) on Thursday provided guidance and other updates, inaddition to news on developments for the Medical Dictionary for Regulatory Activities (MedDRA), following a recent meeting of the MedDRA management committee in Geneva, Switzerland. MedDRA was initially developed by ICH in the late 1990s to provide standardized medical terminology for regulatory purposes and is available at no cost to regulators and to drugmakers on a sli...
  • Regulatory NewsRegulatory News

    Researchers Question FDA's Use of Surrogate Endpoints for Cancer Drug Approvals

    Two researchers are questioning the US Food and Drug Administration's (FDA) use of surrogate endpoints in approving new oncology drugs and the agency's failure to more strictly enforce postmarketing study requirements for these drugs, according to a letter appearing in JAMA Internal Medicine . Drugmakers have increasingly relied on surrogate endpoints to support the approval for new cancer drugs. Instead of demonstrating improvements in overall survival, often called "t...
  • FDA Adopts ICH Guidance on Pharmaceutical Quality

    The US Food and Drug Administration (FDA) released new guidance on 25 July for industry regarding three quality documents released by the International Conference on Harmonization (ICH) related to how manufacturers and sponsors can best prepare these documents for inspection by regulators in the US, EU and Japan. The guidance is co-sponsored by FDA's Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), both of which are in charge ...
  • EMA Wants Harmonized Guideline for IBS Medications

    The European Medicines Agency (EMA) wants better medicinal products to treat irritable bowel syndrome. The disorder, which affects an estimated 20% of the population of western countries by the agency's estimation, is poorly understood and lacks adequate treatment options. Regulators released a "points to consider" (PtC) document in 2003 in an attempt to outline the clinical issues surrounding the development of IBS medications, but it has since then gone without an upda...
  • FDA Opens Innovation Pathway to First Round of Devices

    The US Food and Drug Administration (FDA) is announcing its intention to open up its experimental Innovation Pathway to three medical device companies developing therapies for end stage renal disease (ESRD). FDA's 9 April announcement said the three organizations-CreatiVasc Medical, Blood Purification Technologies Inc. and the University of California-were among 32 product applications covering a wide range of applications.  "The response from innovators exceeded...
  • ICH Releases Updated MedDRA Guidance

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) released 2 April new guidance on using the Medical Dictionary for Regulatory Activities (MedDRA). The two released guidance documents - MedDRA Term Selection: Points to Consider Documents and MedDRA Data Retrieval and Presentation: Points to Consider Documents - provide best practice approaches for data entry (coding) and data retrieval/ana...