Testing for SARS-CoV-2, the virus that causes COVID-19), continues to be in the news, and you may hear the term CLIA in some of these conversations. CLIA refers to the Clinical Laboratory Improvement Amendments, which are amendments to the Public Health Act...
Medicine
Hot New Medical Technologies
Part 1 - Additive Manufacturing of Medical ProductsLately, it seems like science fiction has exploded into the media. From the rapid delivery of effective vaccines against SARS-COV-2 to the first civilians in space, the pace of change is dizzying. This month’s series...
Drug-Drug Interactions
Part 1 - What Are DDIAfter a few months on the topic of funding, we’ll move back into the pharmaceutical space with a discussion of drug-drug interactions. The study of this important class of potential toxicities has developed alongside our understanding of general...
Focus on Women’s Health at the FDA
Recent evidence points to an increased attention on women’s health issues at the FDA. During the FDA’s 2019 Science Forum held in September, Dr. Beverly-Lyn Cook of the National Center for Toxicological Research discussed sex and gender differences in health and...
Setting Drug Expiration Dates
Have you ever wondered how the expiration date is determined for a pharmaceutical product you’ve used? Whether prescription or over the counter, all medications have their expiration dates determined through a stability program in which batches of the product are held...
Standards Organizations Play a Role in Medical Product Regulation
Regulatory bodies worldwide make use of consensus standards developed by independent organizations to establish best practices and conceptual harmony on specialized areas of expertise. Standards organizations for drugs include the regional Pharmacopeia USP, EP, and JP...
For Rare Disease Day 2020 – An Article
As we approach Rare Disease Day this year (February 29th), I’d like to share this PharmaVOICE article on the impact of rare diseases and the efforts underway to address these challenges. As the article notes, while these diseases may be rare because they individually...
Do Value Based Agreements Ensure Patient Access To New Medicines?
Alnylam Pharmaceuticals recently announced a new Value Based Agreement (VBA) framework for their newly approved RNAi medicine to treat acute hepatic porphyria, a group of rare genetic diseases due to one or more deficiencies in the heme biosynthesis pathway in the...