Innovative Science Solutions invites you to join us for an upcoming, FREE webinar, hosted by Innovative Science Solutions, LLC and Kelley Drye & Warren, LLP.
Innovative Science Solutions invites you to join us for an upcoming, FREE webinar, hosted by Innovative Science Solutions, LLC and Kelley Drye & Warren, LLP:
on Tuesday, November 17th from 2-3pm EST.
About the Webinar:
Industry scored an important victory in the recent DOJ vs. Bayer case. But, despite that outcome, health claim enforcement will remain a key priority for the FTC going forward. This presentation is a practical discussion of how the FTC enforcement process works and advocacy steps that companies should consider along the way, including selecting and utilizing scientific experts.
Kelley Drye & Warren special counsel Kristi Wolff and Dr. Steven Weisman, Head of Clinical and Regulatory Support at Innovative Science Solutions, will discuss the advertising enforcement process and provide key takeaways that companies can use to advocate their position before the agency.
We hope you’ll join us!
About the Speakers:
Kristi Wolff is special counsel in the firm’s Washington, D.C. office. Ms. Wolff’s practice focuses on food, dietary supplements, medical devices, and emerging health/wearable technology and privacy issues. She has extensive experience advising clients whose products are within the overlapping jurisdictions of the Food and Drug Administration and the Federal Trade Commission. Having served as in-house counsel in the healthcare and food products industries, Ms. Wolff is particularly attuned to balancing business objectives with legal considerations. Her skill in the consumer protection area was recently recognized as she was named a 2015 Washington, DC, Rising Star by Super Lawyers magazine.
One of Dr. Steven Weisman‘s special skills is his ability to bridge the gap between science and marketing to achieve business goals, so it’s not surprising that he’s sought after by many pharmaceutical and healthcare clients for his competence in recognizing problems and developing solutions. It’s in this capacity that Steve helps clients plan and execute all phases of product marketing and communications platforms from pre-approval through launch to on-going promotion. Steve is well-known for developing and promoting the cardiovascular uses of aspirin for heart attack and stroke prevention. He is a leading authority on the switch of prescription only products to OTC status and is widely published in these areas.
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
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us