White Paper – FDA Draft Guidance Summary Decentralized Clinical Trials for Drugs, Biological Products, and Devices
White Paper from Astrix Clinical Services The US Food and Drug Administration (FDA) has released a draft guidance document on decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. This guidance outlines the FDA’s recommendations for designing, executing, and evaluating these trials and provides guidance on ensuring patient safety and the accuracy of […]
What the FDA’s Quality Metrics Reporting Program Means for Your Lab
Quality metrics are utilized throughout the pharmaceutical industry to assure product quality and facilitate continued improvement of drug manufacturing processes. The FDA has also shown a significant interest in quality metrics, as data detailing compliance with quality standards in drug manufacturing helps the FDA establish compliance and inspection policies, predict and potentially mitigate future drug […]
What the New FDA Guidance on Electronic Records and Signatures Means for Clinical Trials
The digital age is upon us. The FDA has acknowledged the increasing use of computerized systems to manage electronic records generated in the production of FDA-regulated products with applicable regulations and several guidance documents that strive to protect public health by securing digital data integrity. In March of 1997, the FDA released 21 CFR Part […]
Navigating Global Regulations and Guidance Around Data Integrity Guidance
Data integrity provides assurance that data records are reliable and accurate. Regulations meant to ensure data integrity in pharmaceutical laboratories are found in several parts of 21 CFR governing GxP areas and have been enforced by the FDA for decades. While many of these regulations were initially developed for paper-based processes, 21 CFR Part 11 […]
FDA’s Guidance on Genetic Testing: What You Need to Know
In traditional medical care, diseases are typically detected via chemical changes associated with a particular condition and all patients receive a similar dose of a medication as treatment. While this one-size-fits-all approach has led to great advancements in medicine, it has by no means been successful for all patients. Over the last decade, a new […]
Trends in FDA Data Integrity 483s and Warning Letters for Pharmaceutical Companies
The manufacture of pharmaceutical drugs is a highly complex process that involves advanced scientific analysis and instrumentation at all stages of production and storage. In order to guarantee the safety and efficacy of both human and veterinary drugs, the FDA strives to verify data integrity in all cGMP records used to document and guide the […]