Horizon Tool Inc. – 706567 – 06/06/2025
CGMP/Finished Pharmaceuticals/Adulterated
Kenil Healthcare Private Limited – 704786 – 06/12/2025
CGMP/Finished Pharmaceuticals/Adulterated
Nefeteri Wellness – 709332 – 05/30/2025
Unapproved New Drugs
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…
Novel Drug Approvals for 2024
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer & Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Due to Presence of Methanol
Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…