About OCMO Guidance Documents The Office of the Chief Medical Officer (OCMO) provides executive leadership, coordination, and oversight of FDA cross-cutting clinical and public health emergency-related […]

What is homeopathy? Homeopathy is an alternative medical practice that was developed in the late 1700s. Homeopathy is generally based on two main principles: that a […]

Consumers may use various types of unapproved drugs, such as homeopathic products, to treat or relieve different diseases and conditions. These products are often marketed as natural […]

COAQP Email Updates Subscribe for COAQP emails. Receive timely communications such as procedural changes, newly qualified COAs and other COAQP related announcements. COAQP Stages and Submissions Content […]

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess […]

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess […]

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess […]

Background The Fit-for-Purpose (FFP) Initiative provides a pathway for regulatory acceptance of dynamic tools for use in drug development programs. Due to the evolving nature of […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]