www.bigpharmausa.com – 702681 – 06/04/2025

Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

www.buycodeine.us – 702527 – 05/05/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

www.buyprosoma.com – 705973 – 06/10/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Zhejiang Huahai Pharmaceutical Co., Ltd. – 707145 – 06/06/2025

CGMP/Finished Pharmaceuticals/Adulterated

Horizon Tool Inc. – 706567 – 06/06/2025

CGMP/Finished Pharmaceuticals/Adulterated

Pulmonary-Allergy Drugs Advisory Committee Roster

This page contains the Pulmonary-Allergy Drugs Advisory Committee roster, which lists the current members and the current number of vacancies…

What’s New in Regulatory Science

A newsletter on regulatory science for CDER’s stakeholders

Pharmacy Compounding Advisory Committee Roster

This page contains the PCAC roster, which lists the current members and the current number of vacancies for the committee.

Office of New Drugs Custom Medical Queries (OCMQs)

Office of New Drugs Custom Medical Queries (OCMQs) are standardized groupings of similar adverse event terms intended to assist with…

Standard Safety Tables and Figures (ST&Fs)

The Standard Safety Tables and Figures (ST&Fs) are designed to reduce clinical reviewers’ time in generating safety review content and…