The ISS Blog

Providing Scientific Stewardship to the Healthcare Industry and Counsel.

Free to Register – Cancer Progress 2021 Conference [Virtual]
26 April 2021
Free to Register – Cancer Progress 2021 Conference [Virtual]

Cello Health’s Cancer Progress conference will take place on May 4-6, 2021, virtually. Thanks to the generosity of the event sponsors, it is free to register and access partnering. Cancer Progress is now in its 32nd year and it is... Read more

Dr. David Schwartz’s IADC Presentation: The Use of Genetic Testing in the Courtroom [Download Slides]
15 July 2020
Dr. David Schwartz’s IADC Presentation: The Use of Genetic Testing in the Courtroom [Download Slides]

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

The Use of Genetic Testing in the Courtroom: Dr. David Schwartz will be Presenting at the IADC 2020 Virtual Annual Meeting
02 July 2020
The Use of Genetic Testing in the Courtroom: Dr. David Schwartz will be Presenting at the IADC 2020 Virtual Annual Meeting

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

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

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

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

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

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

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

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

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

Will FDA Authorize Your Product Health Claims?
15 June 2020
Will FDA Authorize Your Product Health Claims?

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

WEBINAR ANNOUNCEMENT: What’s in Those Genes?
12 June 2020
WEBINAR ANNOUNCEMENT: What’s in Those Genes?

Genetic Evidence Concerning Causation for Mesothelioma 16 June 2020 at 2pm Eastern Daylight Time. Read more

OTC Monograph User Fees are Cancelled for FY2020
11 June 2020
OTC Monograph User Fees are Cancelled for FY2020

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

Differences between FDA COVID-19 Guidance for Alcohol-Based Hand Sanitizers and Monograph Hand Sanitizers Containing Alcohol
08 June 2020
Differences between FDA COVID-19 Guidance for Alcohol-Based Hand Sanitizers and Monograph Hand Sanitizers Containing Alcohol

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

FDA requirements for coronavirus tests with at-home specimen collection
04 June 2020
FDA requirements for coronavirus tests with at-home specimen collection

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

FDA Announces New Changes to Permitted Marketing Status of OTC Monograph Drugs
02 June 2020
FDA Announces New Changes to Permitted Marketing Status of OTC Monograph Drugs

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

How to apply for an FDA Coronavirus Emergency Use Authorization Letter
27 May 2020
How to apply for an FDA Coronavirus Emergency Use Authorization Letter

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

Talc and Asbestos Defendants Should Monitor and Utilize Published Studies Linking Mesothelioma to Genomic Causes
28 April 2020
Talc and Asbestos Defendants Should Monitor and Utilize Published Studies Linking Mesothelioma to Genomic Causes

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

OTC Monograph Drug Reform Changes the Pharmaceutical Landscape
23 April 2020
OTC Monograph Drug Reform Changes the Pharmaceutical Landscape

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

New Talc and Mesothelioma Studies Provide Unique Risks and Opportunities for Defendants and Insurers
16 April 2020
New Talc and Mesothelioma Studies Provide Unique Risks and Opportunities for Defendants and Insurers

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

Free Access – Coronavirus Science Alerts
30 March 2020
Free Access – Coronavirus Science Alerts

Innovative Science Solutions has been closely following the peer-reviewed scientific literature related to COVID-19. Read more