Providing Scientific Stewardship to the Healthcare Industry and Counsel.
![Dr. David Schwartz’s IADC Presentation: The Use of Genetic Testing in the Courtroom [Download Slides]](http://331534-1414990-raikfcquaxqncofqfm.stackpathdns.com/wp-content/uploads/2020/09/Detail-shot-of-a-meeting-room-184012742_725x483-600x400.jpeg)
On Wednesday July 8, 2020, Dr. David Schwartz of Innovative Science Solutions presented at the IADC 2020 Virtual Annual Meeting on a panel titled The Use of Genetic Testing in the Courtroom. A complimentary copy of the panel presentation is now available for download. Read more
Dr. David Schwartz of Innovative Science Solutions will be presenting at the IADC 2020 Virtual Annual Meeting on a panel titled The Use of Genetic Testing in the Courtroom. Read more
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
According to FDA regulation, conventional food and dietary supplements are allowed to make three categories of claims: health claims, nutrient content claims, and structure/function claims. Read more
Genetic Evidence Concerning Causation for Mesothelioma 16 June 2020 at 2pm Eastern Daylight Time. Read more
Surprising news emerged from the FDA early this week - OTC Monograph User Fee program (OMUFA) facility fees for fiscal year 2020 have been dropped. Read more
On June 1, 2020, the FDA released a statement notifying the public that they have taken additional steps to increase the supply of alcohol-based hand sanitizer during the ongoing COVID-19 pandemic. Read more
Although FDA continues to streamline its process to submit a package requesting an Emergency Use Authorization (EUA) letter for SARS-CoV-2 diagnostic tests, it can be challenging and the precise nature of the submission must be followed. Read more
In a recent webinar hosted by the FDA, Dr. Theresa M. Michele, director of the Office of Nonprescription Drugs at CDER, revealed a significant update on the generally recognized as safe and effective (GRASE) status of hundreds of Monograph ingredients. Read more
Applying for a COVID-19 Emergency Use Authorization (EUA) Letter from FDA is no small feat, even though FDA has tried to simplify the process. Read more
Plaintiff experts having been asserting for decades that all mesotheliomas must be linked to some asbestos exposure. Indeed, this has led to the erroneous (but widespread) view that mesothelioma is a signature disease, only caused by asbestos exposure. Read more
On March 27, 2020, Congress and the House of Representatives with the support of the President signed into law a $2 trillion stimulus bill to address the dramatic economic impact caused by the coronavirus pandemic. Read more
The ToxicoGenomica team has brought genomic causation analysis into over 30 cancer cases for defendants in cases involving benzene, radiation, and asbestos (see here for a description of five of the older cases). Read more
Innovative Science Solutions has been closely following the peer-reviewed scientific literature related to COVID-19. Read more
A valuable web site illustrates the power and speed of using virus genomes to track and understand the global spread of #Covid19. Read more