Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Adjusting for covariates in randomized clinical trials

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.”
  2. Initiation of voluntary recalls

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.”
  3. Bispecific antibody development programs

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Bispecific Antibody Development Programs.”
  4. Determining when a REMS is necessary

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.”
  5. General approach to establish a microbiological ADI

    The European Medicines Agency have published: Scientific guideline: VICH GL36(R2): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI, adopted.