The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more
On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent linkage, “Measures for the Implementation of the Early...more
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more