• Feature ArticlesFeature Articles

    Can Rodent Carcinogenicity Testing Be Eliminated?

    The International Conference on Harmonisation (ICH) Steering Committee has endorsed a concept paper that supports reviewing and harmonizing requirements for carcinogenicity testing in rodents (Topic S1). 1 In line with the 3Rs principle (reduction, replacement and refinement - a major principle of the ICH harmonisation process), the paper suggests it may be possible to reduce or eliminate the need for such testing in a significant number of cases. Such an outcome could ...
  • European Commission: Non-EU Reference Product OK for EU Biosimilars

    The European Commission plans to allow the use of a reference product not authorized in the EU in support of a biosimilar application, according to a  speech  delivered by Health and Consumer Policy Commissioner Dalli at the 18thEuropean Generic Medicines Association Annual Conference. Dalli announced "that after careful analysis of the scientific and regulatory elements, the European Commission will revise its interpretation" of existing EU law. The details o...
  • NIH Drug Development Acceleration Program Expands to Include New Members

    A program launched by the National Institutes of Health (NIH) to repurpose existing advanced-stage drug compounds by partnering with pharmaceutical manufacturers has expanded to more than double its existing membership, the NIH announced on 12 June. The initiative, known as the Discovering New Therapeutic Uses for Existing Molecules program, was founded in May 2012 by the newly-formed National Center for Advancing Translational Sciences (NCATS) to take the existing com...
  • FDA Releases Final ICH Guidance on Genotoxicity Testing and Data Interpretation

    The US Food and Drug Administration (FDA) announced it has released new, harmonized guidance for sponsors looking to conduct genotoxicity testing and data interpretation for human drug products. The guidance, originally put forth in 2008 by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), combines and replaces two existing ICH guidance documents: S2A Specific Aspects for Regulatory Genotoxic...
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    A Conversation With FDA's Human Factors and Accessible Medical Technology Expert

    The US Food and Drug Administration (FDA) released its Draft Guidance for Industry and Food and Drug Administration Staff-Applying Human Factors and Usability Engineering to Medical Devices to Optimize Medical Device Design on 22 June 2011. According to this document medical device manufacturers must perform appropriate human factors engineering and usability testing on their products. To help device makers and regulatory professionals working with devices better under...
  • Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall

    Common are the concerns about good manufacturing practices at pharmaceutical manufacturing facilities. The US Food and Drug Administration sends out dozens, if not hundreds, of warning letters each year to pharmaceutical companies found to be violating basic standards of cleanliness, sterility or quality. Less common are concerns registered by FDA towards pharmaceutical compounding companies, which make medications to unique specifications from scratch using raw material...
  • FDA Releases New ICH Guidance on Preclinical Safety Evaluation

    The US Food and Drug Administration (FDA) released a new addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use's (ICH) guidance on preclinical safety evaluation of biopharmaceuticals, advancing the harmonized regulatory procedure for eventual adoption by the agency. The guidance, "S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6 Addendum)" updates the ...
  • Researchers Gauge Effects of Regulatory Systems on Counterfeit Medicines

    A new paper exploring counterfeit and substandard medicines shows the presence of even a minimally-developed regulatory program can have a profound impact on ensuring consumers have access to genuine, quality medicines. The study, " Counterfeit or Substandard? The Role of Regulation and Distribution Channel in Drug Safety ," was published as a National Bureau of Economic Research (NBER) working paper and authored by Roger Bate and Aparna Mathur of the American Enterpri...
  • Japan: English Translation of First-in-Human Studies Guidance Released

    Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is announcing the publication of an English translation of a guidance document detailing how first-in-human studies are to be conducted. The Guidance ,  Establishing Safety in First-in-Human Studies during Drug Development, provides PMDA's advice on how to facilitate "the smooth transition from non-clinical to early clinical study during the drug development process."  It applies to new chemical ...
  • Study: Most Drugs Lacking Information on Adequate Pediatric Use

    • 09 May 2012
    A study conducted by researchers at the US Food and Drug Administration (FDA) finds fewer than half of all pharmaceutical products on the market do not contain any information for how the drug should be used safely in pediatric populations, reports Reuters . The study, published in the Journal of the American Medical Association , notes just 46% of products listed in the electronic Physicians' Desk Reference contained information to ensure safe pediatric use, notes Me...
  • EMA Adopts Guidance on Medical Products Containing Genetically Modified Cells

    The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified cells. The scientific guideline addresses the three main areas of drug development: quality considerations within the manufacturing process, non-clinical testing and clinical testing. EMA notes genetically modified cells may either be used as therapies themselves or as part of t...
  • New Biologic Sterility Regulation Issued by FDA

    The US Food and Drug Administration (FDA) is announcing its amendment of existing sterility test requirements for biological products, which it said will provide greater flexibility for manufacturers and encourage the use of cutting-edge technologies to assure the safety of biological products. In its 2 May Federal Register posting entitled Amendments to Sterility Test Requirements for Biological Products , FDA said its rule is "intended to promote improvement and i...