Tag Archives: life sciences

AdvaMed Releases Updated Code of Ethics, Effective 2020

The Advanced Medical Technology Association (AdvaMed) has published its updated Code of Ethics. The updated code will become effective on January 1, 2020. AdvaMed has also published an overview of changes.

The updated AdvaMed Code now includes “Key Concepts” at the beginning of each section, with visuals, graphics, callout boxes, examples, explanations and FAQs.

The AdvaMed Code provides medical technology companies with guidance on ethical interactions and relationships with healthcare professionals (HCPs) to ensure that medical decisions are based on the best interests of the patient.

Because the medical technology industry is highly divergent, the AdvaMed Code drafters recognize no single compliance program fits each company. Therefore, AdvaMed encourages companies to adopt an “appropriately tailored” ethics and compliance program, accounting for the specific types of risks that apply to their operations. Companies adopting the AdvaMed Code are encouraged to submit to AdvaMed an annual certification stating adoption of the AdvaMed Code and implementation an effective compliance program.

Read the full Duane Morris Alert.

CDER’s New MAPP on Risk-Based Site Selection Model for Routine Inspections

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.

We invite you to read the full text of this Duane Morris Alert on the firm website.

Five Good Habits of University Researchers Launching Spinouts

By Sandra G. Stoneman and Matthew C. Mousley

Photo of attorney Sandra Stoneman
Sandra G. Stoneman
Photo of attorney Matthew Mousley
Matthew C. Mousley

If you are a university researcher interested in launching a startup based on an invention developed in your lab, below is a list of some key guidelines to keep in mind as you start your company:  Continue reading Five Good Habits of University Researchers Launching Spinouts

American Chemical Society Entrepreneurial Showcase 2015

The American Chemical Society held its annual Entrepreneurial Showcase in San Diego at Jannsen Labs (J&J Research Labs) in April 2015. ACS holds the biannual event, showcasing entrants from across the U.S., at Boston, Washington D.C., or San Diego.

The Showcase was a pitch event for emerging companies to present their technology, business plans, and answer some brief questions in front of angel investors, venture capitalists, corporate scouts, and Continue reading American Chemical Society Entrepreneurial Showcase 2015