Zachary Brennan from in-pharmatechnologist.com wrote an interesting article on the European Medicines Agency’s (EMA) move for pharmaceutical companies to produce a risk-management plan (RMP) for the public. The document will contain the known and unknown issues and safety concerns that go along with the medicine and what measures should be taken to prevent injury or illness. The EMA’s plan is to first focus on the creation of RMPs for new products in 2014, with the potential to look at products created in previous years. The RMP is just another addition to the agency’s summaries called the European public assessment report. To read the full article click here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
Life Science Accelerated
Our experts are dedicated to expediting life science product development regulatory pathways.