Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
In response to the outbreak of a pneumonia-like disease caused by coronavirus (COVID-19), Chinese regulatory authorities adopted a few emergency measures under certain “Special Review and Approval Procedures” to fast-track...more
Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications - On 28 March China's National Medical Products Administration (NMPA) published a list of an...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
This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more
As expected, the Fed announced yesterday that it was holding current interest rates steady and would be slow to push rates up while the economy tiptoes toward stability. Much more from Chair Yellen and economists’ reaction...more