Blog - FDA Copilot

July 9, 2023 Artificial Intelligence FDAcop

Update from the FDA: June 6, 2023

The U.S. Food and Drug Administration (FDA) has released a summary of recent news and updates. First, the FDA issued a letter to health care providers recommending conservation strategies for non-sterile, single-use pneumatic tourniquet cuffs. The agency provided a list of best practices for cleaning and sterilization/disinfection of these devices and recommended the use of […]

July 9, 2023 Artificial Intelligence FDAcop

Gratitude Expressed | Analysis of Life Sciences

The FDA’s Office of Pharmaceutical Quality (OPQ) recently published a report on the current state of pharmaceutical quality. However, there are some concerns and gaps in the report’s information. The creation of OPQ was aimed at addressing the lack of quality-related information available outside of the product review process and post-approval inspections. The office aims […]

July 9, 2023 Artificial Intelligence FDAcop

FDA News Roundup: June 9th, 2023

In a recent announcement, the U.S. Food and Drug Administration (FDA) provided updates on various topics related to healthcare and medical devices. Here are the key highlights: Oxygenator Device Recall: The FDA issued a letter to healthcare providers and facilities regarding a recall notice by Getinge/Maquet for Quadrox Oxygenators. The letter includes recommendations for healthcare […]

July 9, 2023 Artificial Intelligence FDAcop

Regulatory Experts Provide an Exclusive Analysis on Life Sciences

The FDA’s Office of Pharmaceutical Quality (OPQ) has recently released a report titled “State of Pharmaceutical Quality,” which aims to provide insight into the current state of quality in the pharmaceutical industry. However, upon closer analysis by AgencyIQ, it becomes apparent that the report is lacking in certain areas and contains some potentially misleading information. […]

July 8, 2023 Artificial Intelligence FDAcop

FDA Releases Draft Guidelines for Decreasing Microbial Contamination in Tattoo Inks

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to help manufacturers and distributors prevent microbial contamination in tattoo inks. With approximately 30 percent of people in the U.S. having a tattoo, it is important to ensure that tattoo inks are free of contamination to prevent infections and serious injuries. The FDA […]

July 8, 2023 Artificial Intelligence FDAcop

FDA News Roundup: June 13, 2023

The U.S. Food and Drug Administration (FDA) has released a summary of recent news from the agency. One of the highlights is the publication of an article by Kerry Jo Lee, M.D., Associate Director for Rare Diseases at the FDA, on the Accelerating Rare disease Cures (ARC) Program. The ARC Program aims to increase the […]

July 8, 2023 Artificial Intelligence FDAcop

Bausch + Lomb Remains on Acquisition Path: Buys J&J Eye Drops for $106M

Bausch + Lomb, a global eye care company, is expanding its over-the-counter presence by acquiring Johnson & Johnson’s Blink line of eye drops for $106.5 million. The acquisition includes the Blink product line, which consists of six eye drops and contact lens drops for rewetting and lubricating the eye. Bausch + Lomb will finance the […]

July 8, 2023 Artificial Intelligence FDAcop

FDA Updates: June 16, 2023

The U.S. Food and Drug Administration (FDA) has provided an at-a-glance summary of news from around the agency. Here are some key highlights: 1. COVID-19 Vaccine Formulation for Fall/Winter 2023-2024: The FDA has advised COVID-19 vaccine manufacturers to develop vaccines with a monovalent XBB.1.5 composition for the upcoming fall and winter seasons. The agency expects […]

July 8, 2023 Artificial Intelligence FDAcop

Exclusive Article – Expressing Gratitude

A new report from the E.U. Big Data Steering Group (BDSG), EMA, and the European Medicines Regulatory Network (EMRN) shares experience obtained from real-world data (RWD) based studies between September 2021 and February 2023. The aim of the study was to establish a workable framework for using real-world evidence (RWE) for regulatory cases within the […]

July 8, 2023 Artificial Intelligence FDAcop

FDA Initiates Pilot Program to Mitigate Risks in Utilizing Laboratory Developed Tests for Cancer Biomarker Identification

The U.S. Food and Drug Administration (FDA) has launched a new voluntary pilot program aimed at improving the selection of cancer treatments for patients. The program focuses on certain oncology drug products used with corresponding in vitro diagnostic tests. These tests provide essential information for the safe and effective use of specific cancer treatments. The […]