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

Image Medical and veterinary products save lives every day. FDA-regulated products such as blood pressure medicine, chemotherapy and MRI machines help people and animals live longer […]

The Office of the Chief Medical Officer (OCMO) is sharing the following lists of guidance documents for public review and input: Guidance documents we intend to […]

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 […]