U.S. Food and Drug Administration

FDA is working with U.S. Government partners, including CDC, and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China.

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FDA Takes Action to Address Novel Coronavirus with Medical Countermeasures

FDA is working with U.S. Government partners, including CDC, and international partners to closely monitor the outbreak caused by a new coronavirus first identified in Wuhan City, Hubei Province, China.

In light of the public health emergency declared for the Novel Coronavirus, visitors to FDA campuses and buildings may be asked questions related to recent international travel.

Food

Drugs

Medical Devices

Radiation-Emitting Products

Vaccines, Blood, and Biologics

Animal and Veterinary

Cosmetics

Tobacco Products

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FDA’s Technology Modernization Action Plan

The plan describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data, and analytics—to advance FDA’s public health mission.

Science-related icons juxtoposed on a background of prescription paperwork

Fostering Drug Competition

Increasing the availability of generic drugs helps to create competition in the marketplace, helping make treatment more affordable and increasing access to healthcare for more patients.

24 portraits of smiling patients with rare diseases and caregivers in a grid and a banner across the top with a pattern of interconnected handprints behind animated text that reads "We recognize rare diseases. We recognize you." and "Photos of rare disease patients and caregivers."

Rare Disease Day 2020

On February 29, FDA will join the global observance of Rare Disease Day, which was created to raise awareness about the 7,000 known rare diseases, many of which have no treatment. Learn more and register to attend the meeting.

Feb 20

FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications

Feb 20

FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

More Press Announcements

Newsroom Meetings Testimony Speeches

Feb 20

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing

Drugs

Feb 19

Saratoga Potato Chips, LLC Issues Allergy Alert on Undeclared Milk in Kroger Sweet & Mesquite BBQ Potato Chips

Food & Beverages

Feb 14

CJ Foods Voluntarily Recalls Annie Chun’s Japanese-Style Teriyaki Noodle Bowls Due To Undeclared Peanuts

Food & Beverages

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Row of portraits of 8 rare disease patients and their caregivers below text that reads "We recognize rare diseases. We recognize you." and many hand prints in the form of a wave in the background.

Rare Disease Day 2020: FDA Continues Important Work on Treatments for Rare Diseases

FDA is undertaking a number of efforts to advance the development of medical products to meet the needs of the rare disease population.

four overlapping photos in a row showing, from left to right, closeup of scientist's gloved hand holding generic drug samples, female scientist looking into microscope, consumer removing prescription medicine bottle from medicine cabinet, young African American cancer patient wearing a head scarf looking at the camera and smiling

Serving Public Health Paramount in a Successful 2019 for FDA’s Generic Drug Program

Our 2019 numbers marked another successful year for the FDA’s generic drug program and resulted in more treatment choices and access to affordable medicines.

FDA scientists studying cyclospora sample under an electron microscope

FDA Arming Itself with Science to Help Prevent Cyclospora Infections

The FDA is working to help protect consumers from the foodborne illness that Cyclospora can cause.

More FDA Voices

Feb 21

Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry

Biologics, Drugs

Feb 21