Blog - FDA Copilot

July 6, 2023 Artificial Intelligence FDAcop

FDA’s Proposed Unified Human Foods Program Gets an Update: Introducing a Fresh Model for the Office of Regulatory Affairs

The U.S. Food and Drug Administration (FDA) has announced updates to its proposal for a unified Human Foods Program (HFP) and a new model for the Office of Regulatory Affairs (ORA). The changes aim to enhance coordination, prevention, and response activities across the FDA and improve the agency’s ability to support public health goals. The […]

July 6, 2023 Artificial Intelligence FDAcop

Latest FDA Updates: June 27, 2023

The U.S. Food and Drug Administration (FDA) has released several updates and guidance documents to improve food safety, drug development, orthopedic implants, and consumer-friendly labeling. One of the updates includes new frequently asked questions and tools for industry regarding the FDA Food Safety Modernization Act (FSMA) Food Traceability Rule. This rule aims to identify and […]

July 5, 2023 Artificial Intelligence FDAcop

FDA and FTC Issue Warnings to Six Companies Selling Illegitimate Food Items with Delta-8 THC

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have sent warning letters to six companies for illegally selling food products containing Delta-8 tetrahydrocannabinol (THC), also known as delta-8 THC. These products resemble traditional foods like chips, cookies, candy, gummies, or other snack items, and can be easily mistaken as such. […]

July 5, 2023 Artificial Intelligence FDAcop

Butterfly Network Introduces AI Tool for Point-of-Care Lung Ultrasounds

Massachusetts-based medical device company, Butterfly Network, has launched its AI tool, the Auto B-line Counter, commercially. The tool uses artificial intelligence to provide medical practitioners with an accurate B-line count from a short lung ultrasound clip. B-lines are vertical, bright lines that indicate lung conditions such as pulmonary congestion or volume overload. By automating the […]

July 5, 2023 Artificial Intelligence FDAcop

Gratitude Expressed: Exclusive Article

The FDA has released a final guidance on how companies should present quantitative information about the risks and effectiveness of drugs in direct-to-consumer advertising. The guidance, which is meant to make drug advertising more consumer-friendly, includes recommendations on presenting efficacy and risk information using words, numbers, or visual aids. The FDA also advises using absolute […]

July 5, 2023 Artificial Intelligence FDAcop

La FDA ofrece detalles actualizados sobre la propuesta del programa de alimentos humanos unificado, incluyendo el reciente enfoque para la Oficina de Asuntos Regulatorios.

The U.S. Food and Drug Administration (FDA) has provided an update on its proposal to create a unified Human Foods Program (HFP) which includes a new model for the Office of Regulatory Affairs (ORA). These additions to the FDA commissioner’s proposal, announced earlier this year, will further enhance coordination, prevention, and response activities throughout the […]

July 5, 2023 Artificial Intelligence FDAcop

Article Exclusively Authored by Industry Regulators

The FDA has released a final guidance on how companies should present quantitative information about the risks and effectiveness of drugs in direct-to-consumer advertising. The guidance, which was cleared by the White House four months ago, includes changes in the way information about control groups should be presented in drug advertisements. The FDA’s Center for […]

July 4, 2023 Artificial Intelligence FDAcop

FDA Grants Approval for First Cellular Therapy to Treat Type 1 Diabetes Patients

The U.S. Food and Drug Administration (FDA) has approved Lantidra, a cellular therapy made from deceased donor pancreatic cells, for the treatment of type 1 diabetes. Lantidra is intended for adults with type 1 diabetes who are unable to achieve target blood glucose levels due to severe hypoglycemia (low blood sugar) despite intensive management and […]

July 4, 2023 Artificial Intelligence FDAcop

Gratitude Expressed for Life Sciences Analysis

July is expected to be a slow month for regulatory actions, with only a small number of FDA-hosted and industry-hosted meetings scheduled. There are also not many legislative or user fee-driven deadlines for the FDA to meet. However, when the FDA released its updated Unified Agenda in June, it listed several regulations that it expected […]

July 4, 2023 Artificial Intelligence FDAcop

First Gene Therapy for Severe Hemophilia A in Adults Approved by FDA

On June 29, 2023, the U.S. Food and Drug Administration (FDA) approved Roctavian, a gene therapy for the treatment of severe hemophilia A in adults without pre-existing antibodies to adeno-associated virus serotype 5. Severe hemophilia A is a rare genetic bleeding disorder that affects primarily males and is characterized by low levels of clotting Factor […]