JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Given its growing role as the “pharmacy to the world,” FDA Commissioner Robert Califf, M.D., recently took a trip to India and offered some of his (and FDA's) views upon his return. During his visit, Commissioner Califf met...more
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such as the United States Food...more
On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in...more
Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further underscored the immense...more
As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
Our Food, Drug & Device/FDA Group breaks down the new Food and Drug Administration guidance on data integrity for current good manufacturing practices (CGMPs) and what it means for the drug industry....more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more
The Food and Drug Administration recently released draft guidance for the industry entitled “Data Integrity and Compliance with CGMP [Current Good Manufacturing Practices].” While the draft is not legally binding on industry...more
On April 14, 2016, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Data Integrity and Compliance with CGMP Guidance for Industry” (the “Draft Guidance”). Noting that the FDA has increasingly...more
The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies. In recent years, issues involving the integrity of and controls around manufacturing data...more