FDA yesterday released a finalized guidance on “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies.” At this time, FDA said it intends to exercise enforcement discretion with respect to such requirements under limited circumstances as described in section II of this guidance. This policy does not apply to fecal microbiota for transplantation (FMT) that is obtained from a stool bank (an establishment that collects, prepares, and stores FMT products for distribution to other establishments, healthcare providers, or other entities for use in patient therapy or clinical research). An establishment that collects or prepares FMT products solely under the direction of licensed healthcare providers for the purpose of treating their patients (e.g., a hospital laboratory) is not considered to be a stool bank under this guidance.
The WHO has begun a 1-year phase-out of the term “monkeypox” in favor of “mpox,” the agency announced yesterday. “When the outbreak of monkeypox expanded earlier this year, racist and stigmatizing language online, in other settings and in some communities was observed and reported to WHO,” the agency said. “In several meetings, public and private, a number of individuals and countries raised concerns and asked WHO to propose a way forward to change the name.” The action affects ICD-10 codes and other references to the disease caused by this virus. The naming of the virus itself is the responsibility of the International Committee on the Taxonomy of Viruses, which has a process underway for the name of the monkeypox virus, WHO said earlier this year.