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.
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
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