by FDA on August 5, 2021 at 7:14 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 August 5, 2021 at 6:48 pm

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

by FDA on August 5, 2021 at 5:22 pm

The qualification process comprises FDA review of specific documents submitted to the AMQP in three successive stages

by FDA on August 5, 2021 at 3:34 pm

FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs.

by FDA on August 5, 2021 at 2:31 pm

This page contains the Medical Imaging Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee.

by FDA on August 5, 2021 at 1:41 pm

Generic Drug Facilities, Sites and Organization Lists

by FDA on August 5, 2021 at 1:41 pm

In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs.

by FDA on August 4, 2021 at 8:55 pm

This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to present).

by FDA on August 4, 2021 at 7:47 pm

Since the Drug Supply Chain Security Act (DSCSA) was enacted in 2013, FDA has issued the following guidance and policy documents

by FDA on August 4, 2021 at 7:22 pm

Fetal Pharmacology and Therapeutics OCTOBER 21 – 22, 2021

by FDA on August 4, 2021 at 6:46 pm

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022.

by FDA on August 4, 2021 at 5:53 pm

Science-based health and safety information you can trust.

by FDA on August 4, 2021 at 5:33 pm

From Our Perspective

by FDA on August 4, 2021 at 5:32 pm

FDA recently approved Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection in adult and pediatric patients receiving lung transplantation.

by FDA on August 4, 2021 at 4:28 pm

Procedural

by FDA on August 4, 2021 at 2:31 pm

GDUFA III Minutes

by FDA on August 4, 2021 at 2:06 pm

Oncology (Cancer) / Hematologic Malignancies Approval Notifications

by FDA on August 4, 2021 at 2:00 pm

Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)

by FDA on August 3, 2021 at 6:11 pm

The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public

by FDA on August 3, 2021 at 5:32 pm

Providing guidance on compounded drugs