by FDA on October 23, 2021 at 2:30 am

Four FAERS summary statistics reports updated with data through December 31, 2013.

by FDA on October 22, 2021 at 8:39 pm

Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.

by FDA on October 22, 2021 at 7:02 pm

FDA to hold public meeting to discuss proposed recommendations for reauthorization of the Generic Drug User Fee Amendments for fiscal years 2023 through 2027.

by FDA on October 22, 2021 at 6:57 pm

Coronavirus (COVID-19) Update: October 22, 2021

by FDA on October 22, 2021 at 6:55 pm

Want to know what’s new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

by FDA on October 22, 2021 at 6:18 pm

Quarterly IID Change Log displays changes made since the previous quarterly IID publication.

by FDA on October 22, 2021 at 5:47 pm

Generic Drug Facilities, Sites and Organization Lists

by FDA on October 22, 2021 at 5:47 pm

October 28, 2021: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

by FDA on October 22, 2021 at 3:28 pm

SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry.

by FDA on October 21, 2021 at 8:19 pm

The Food and Drug Administration is helping women and their health care providers to learn more about the effects of medicines during pregnancy and breastfeeding.

by FDA on October 21, 2021 at 6:34 pm

Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.

by FDA on October 21, 2021 at 6:29 pm

Patient-focused drug development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. The primary goal of patient-focused drug development is to better incorporate the patient’s voice in drug development and evaluation. FDA welcomes patient stakeholders and others to submit useful information or patients experience data related to their patient community. The resources on this page are here for your convenience and do not indicate endorsement of their content by FDA.

by FDA on October 21, 2021 at 5:45 pm

This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

by FDA on October 21, 2021 at 4:47 pm

Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805

by FDA on October 21, 2021 at 4:38 pm

CDER Scientific Reviews Supporting EUA for Therapeutic Products

by FDA on October 21, 2021 at 3:06 pm

This workshop engages experts in the field of modeling & simulation in the generic and new drug industries, academia, & relevant stakeholders to explore, identify & recommend best practices for the development and assessment of model integrated approaches for BE assessment of LAI drug products.

by FDA on October 21, 2021 at 12:50 pm

Guidance documents represent the FDA’s current thinking on a particular subject. New guidance documents are listed here for three months.

by FDA on October 21, 2021 at 12:49 pm

Data Standards for Drug and Biological Product Submissions Containing Real-World Data

by FDA on October 20, 2021 at 7:48 pm

Remarks by Janet Woodcock, MD Acting Commissioner of Food and Drugs 2021 NORD Breakthrough Summit October 19, 2021 Washington, DC

by FDA on October 20, 2021 at 7:30 pm

Merck (NYSE: MRK), known as MSD outside the United States and Canada, is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) 500mg for intravenous use, Lot 934778, Exp June 2022. Because treatment with CUBICIN is likely to be initiated at a hospital or other monitored healthcare se