• Regulatory NewsRegulatory News

    FDA issues clinical pharmacology draft guidance for antibody-drug conjugates

    The US Food and Drug Administration (FDA) on Monday issued a draft guidance on clinical pharmacology considerations for sponsors interested in developing antibody-drug conjugates (ADC). There is currently no guidance addressing these drugs, said the agency.   The guidance provides recommendations for ADCs, which are defined as an antibody or antibody fragment conjugated to at least one payload molecule via a chemical linker for treating cancer. They are regulated as ...
  • Regulatory NewsRegulatory News

    EU official says ICH Q6B is outdated and needs revision

    The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concepts embodied in other ICH guidelines, according to a regulator from the EU.   Mats Welin, a senior expert for vaccines and monoclonal antibodies (MAbs) for the Swedish Medical Products Agency, made this assertion at the 30 November webi...