Greenberg Traurig’s Life Sciences & Medical Technology Group will be hosting the biotech program, "Accessing the US Market - Key FDA Considerations," on January 13 at GT's San Francisco office. GT Shareholder Nick Diamond will also be a speaker. This seminar will offer a comprehensive guide for companies navigating the complex regulatory landscape of the U.S. market. Attendees will gain insights into the FDA's requirements and expectations for the successful launch of drug and medical device products.
Program Topics Will Include:
1. Understanding FDA Regulations: A detailed overview of key regulatory frameworks for pharmaceuticals and medical devices.
2. Effective Communication with the FDA: Best practices for establishing and maintaining productive and strategic interactions with the agency.
3. Preparation of Product Submissions: Practical advice on generating high-quality product submissions to expedite the review process.
This program is ideal for senior executives, senior business development managers, regulatory affairs professionals, product managers, and anyone involved in bringing healthcare products to the U.S. market. This session will equip participants with the tools to navigate regulatory hurdles, avoid common pitfalls, and ensure a smoother path to market entry.