Evaluation of FDA Labeling Changes Related to PREA Safety-Waivers.

PURPOSE: The Pediatric Research Equity Act (PREA) gives the US Food and Drug Administration (FDA) authority to require pediatric studies for drug and biologics products under certain circumstances and to waive this requirement in some, or all, pediatric ages. When studies are waived for safety, PREA stipulates the safety issue must be described in labeling. This study assessed the rate of including waiver-related safety information in labeling. METHODS: FDA databases were reviewed to determine the number of safety-related pediatric study waivers and issued from December 2003 through August 2020, and corresponding labeling to establish when relevant safety information was included. Descriptive comparisons were conducted across Cohort 1: December 2003-2007, Cohort 2: 2008-2011, Cohort 3: 2012-2015, and Cohort 4: 2016-August 2020. RESULTS: One hundred sixteen safety waivers were issued [Cohort 1 (n = 1); Cohort 2 (n = 38), Cohort 3 (n = 37), and Cohort 4 (n = 40)] for 84 unique drugs or biologics. Most (106 of 116; 91%) waiver-related safety issues were described in labeling [Cohort 1 (1 of 1), Cohort 2 (33 of 38), Cohort 3 (33 of 37), and Cohort 4 (39 of 40)]. Safety waivers were most common in patients ≤ 17 years (n = 40) and least common in patients ≤ 6 months (n = 15). Products for infections (n = 32) were the most common group receiving safety waivers; 17 for non-antiviral anti-infective products including treatments for dermatologic infestations/infections, and 15 for antiviral products. CONCLUSION: The data confirm that FDA consistently describes waiver-related safety information in drug/biologic product labeling since the inception of PREA in December of 2003.

Regulatory aspects of total product life cycle.

Total Product Life Cycle (TPLC) is a conceptual framework for assessing any product or service (medical or otherwise). This article will address how the Center for Devices and Radiological Health of the U.S. Food and Drug Administration utilizes TPLC in a regulatory paradigm. TPLC will help guide the regulation of market-driven evolution of medical devices and radiation-emitting products from conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.

Consumers report glucose meter problems to FDA.

OBJECTIVE: Glucose meters have unquestionable clinical utility, particularly in management of diabetes mellitus. U.S. Food and Drug Administration (FDA) surveillance activities include monitoring adverse event reports from healthcare professionals, manufacturers, and lay users. METHODS: To gain insight into problems reported to FDA on glucose meters, we analyzed reports received over a 3-year period (2000-2002) from all sources (mandatory and voluntary) and focused on reports from users. RESULTS: The vast majority of in vitro diagnostic device (IVD) reports (84%, n = 18,959) were on glucose meters, with 333 glucose meter reports from users. Among the user reports, the most common problems were false high or low values and erratic values. Unique issues reported included purchase of incorrect glucose meter strips, calibration problems, and misunderstanding how FDA regulates glucose device performance. CONCLUSION: The FDA gains valuable insight from and encourages user reports.