U.S. Food and Drug Administration (FDA)

The Food and Drug Administration (FDA), also known as USFDA, is a key federal agency under the Department of Health and Human Services in the United States government. Its main role is to safeguard and enhance public health by overseeing various areas such as food safety, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, devices that emit electromagnetic radiation, cosmetics, animal food and feed, as well as veterinary products. Notably, in 2017, around 75% of the FDA's budget, which is about $700 million, came from pharmaceutical companies, thanks to the Prescription Drug User Fee Act.

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CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative | FDA

1 month ago | fda.gov

CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
Aspartame and Other Sweeteners in Food | FDA

1 month ago | fda.gov

High-intensity sweeteners are used as sugar substitutes because they are many times sweeter than sugar but contribute only a few to no calories.
Project Areas by Topic | FDA

2 months ago | fda.gov

Data for projects funded between FY2012 and FY2024
Vaccines for Covid-19: A Personal Reflection

Jan 13, 2025 | fda.gov | Robert M. Califf

By: Robert M. Califf, M.D., Commissioner of Food and DrugsCOVID-19—the disease caused by the SARS-CoV-2 respiratory virus—has taken a terrible toll. The World Health Organization (WHO) estimates that COVID-19 is responsible for at least 1.2 million deaths in the U.S. and over 7 million deaths worldwide.1 Amid this catastrophic wave of death and remarkably severe illness, multiple emergency policies were enacted at every level of government and in private industry.
FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Oysters from a Portion of Hammersley Inlet Growing Area, Washington State, Potentially Contaminated with Norovirus | FDA

Jan 5, 2025 | fda.gov

Washington State is conducting a recall of shellstock oysters harvested from 12/02/2024 to 12/17/2024 by Ruco’s Shellfish from Hammersley Inlet growing area in WA due to a norovirus outbreak.
FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Oysters and Manila Clams from Pickering Passage, Washington Potentially Contaminated with Norovirus | FDA

Jan 5, 2025 | fda.gov

Washington has recalled oysters and Manila clams harvested from 11/15/2024 to 12/11/2024 by Rudy’s Shellfish (WA-1590-SS) from the Pickering Passage growing area in Washington due to a Norovirus outbreak.
Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force | FDA

Dec 21, 2024 | fda.gov

CDRH has two Payor Programs to facilitate communication between device manufacturers, payors, and others to potentially shorten the time between FDA approval/clearance and patient access. These programs include Early Payor Feedback Program and Parallel Review.
Insertion Tube Recall: FHC Removes microTargeting Insertion Tube Sets due to a Manufacturing Size Error That May Lead to Patient Harm | FDA

Nov 29, 2024 | fda.gov

FHC microTargeting Insertion Tube Sets guide instruments during neurosurgery. The reducing cannula in a specific lot is 20mm too long.
Gracie’s Kitchen’s Inc. Recalls Read-To-Eat Products Manufactured Between 11/4 and 11/13/24 Because of Possible Health Risk

Nov 28, 2024 | fda.gov | Gracie’s Kitchens

Summary Company Announcement Date: November 28, 2024 FDA Publish Date: November 28, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness/Listeria monocytogenes Company Name: Gracie’s Kitchens Inc.
Investigation of Avian Influenza A (H5N1) Virus in Dairy Cattle | FDA

Nov 8, 2024 | fda.gov

The USDA, the FDA, and the CDC, along with state partners, continue to investigate an outbreak of Avian Influenza A (H5N1) impacting poultry, dairy cows, and people in multiple states.