A partial United States (US) Government shutdown has hindered the Food and Drug Administration’s (FDA’s) ability to accept and review regulatory submissions. A notice from the FDA on Government funding lapses, which started in December 2018, states that currently the FDA has no legal authority to collect user fees assessed for their 2019 fiscal year, which prevents the FDA from accepting new regulatory submissions such as 510(k)s and Premarket Applications (PMA) that require fees until Congress and the White House restore full funding. If you are planning to submit applications for US market authorisation in early 2019, you should factor these operational delays at FDA into your commercialisation plans. Read more “Partial US Government shutdown is straining the FDA” →

From their meeting in December, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting, the CHMP announced the recommendations of seven medicines for approval, including two orphan medicines. Read more “Highlights from the December CHMP meeting” →

The Food and Drug Administration (FDA) have released two new draft question and answers (Q&A) documents on biosimilar development, and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and two final guidance documents covering the same topics, plus one proposed rule which amends the definition of a biological product. Read more “FDA introduces expectations for biosimilars, soon to be biologics” →

The Food and Drug Administration (FDA) have released a new framework which discusses how the agency will use real world evidence (RWE) and real-world data (RWD) to assist companies win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements. Read more “FDA framework to advance use of real-world evidence to support development of drugs and biologics” →