Pharmaceutical companies and research advocacy groups are asking the US Food and Drug Administration (FDA) to clarify some of the provisions of its recently updated expanded access draft guidance. Commenters inquired about the agency setting a response time frame for responding to expanded access waivers, when children qualify for expanded access drugs and expanded access to medical devices.
In November, FDA published the updated draft guidance for when investigational new drugs (IND) can be used under expanded access. It includes new frequently asked questions about how expanded access can be implemented based on new regulatory access and statutory requirements under the 21st Century Cures Act (Cures Act) and FDA Reauthorization Act of 2017 (FDARA). (RELATED: FDA updates guidance on expanded access for investigational drugs under IND, Regulatory Focus November 2 2022)
Drugmakers Bayer and Novartis were among the stakeholders who submitted comments to the draft guidance.
Bayer asked FDA to make it clearer that under certain circumstances, the agency will grant a waiver for non-emergency expanded access to drugs where an institutional review board (IRB) does not need to review the drug’s use but rather its use can be waived by the IRB chair or designee. The drugmaker also asked FDA to state explicitly that it plans to give a decision on the waiver within 15 days of the request…
