Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Medicines for children and rare diseases

    The European Commission has launched a public consultation on an evaluation of the legislation on medicines for children and rare diseases (medicines for special populations).
  2. Quantitative efficacy and risk information in direct-to-consumer promotional labeling and advertisements

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.”
  3. Development of drug and biological products for treatment of hematologic malignancies

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.”
  4. Early drug development and the role of pre-investigational New Drug Application meetings for rare diseases

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.”
  5. Developing targeted therapies in low-frequency molecular subsets of a disease

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.”