The FDA's electronic Submission Template and Resource (eSTAR) program currently supports medical device submissions for 510(k) clearance or De Novo evaluation. The program is voluntary, but these templates will be mandatory once the FDA publishes an adoption timeline....
Medical Products
What Does CLIA Mean For Laboratory Testing?
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...
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...
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...
What are the Pharmacopoeia?
Traditionally, pharmacopoeia is a book of medicinal drugs with their effects and directions for use. Today, the pharmacopoeia are regional organizations devoted to creating and maintaining standards to ensure public health. Part of that mission includes maintaining a...
2020 Good for Pharmaceuticals and Life Sciences Deals?
There’s a lot of investment capital floating around out there, and the Pharmaceuticals and Life Sciences (PLS) sector could benefit this year. According to a report by international accounting firm PwC, there’s considerable money and investment interest in the space,...