Monkeypox: Anvisa guides health services on case management

The National Health Surveillance Agency (Anvisa) provides guidance on prevention and mitigation measures for Monkeypox in hospitals, clinics and other health services that provide care to suspected and confirmed cases of the disease.

FDA publishes ICH Q12 guideline for Post Approval CMC changes

Overview FDA facilitates the management of post approval CMC to harmonize regulatory approval of drugs with ICH Q12 guideline. This guidance applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device combination products that meet the definition of a pharmaceutical or biological product.  Regulatory tools and […]