Prior to their webinar on Thursday, October 7, Coleen Klasmeier and Jaime Jones consider some of the effects of the final rule.
FDA’s final rule to amend its medical product ‘intended use’ regulations has now been in effect since September 1. The changes which the final rule makes to the definition of intended use, as interpreted by FDA in the accompanying preambles, expand the types of evidence that are deemed relevant to determining whether a lawfully marketed drug or device has a new intended use and whether a product is intended for use as a drug or device.
On World Patient Safety Day, Torrey Cope in Washington, D.C., Chen Yang in Beijing, and Olivier Goarnisson in Geneva consider one big pharmacovigilance question raised by the increasingly patient-centric way in which life science companies are doing business today: How to treat the data collected by the apps provided with drugs and devices.
This month’s presidential Executive Order on economic competitiveness in the U.S. includes a number of initiatives relating to drug pricing. There are calls to combat “excessive pricing,” to reduce the cost of drugs to the Federal government, to address “price gouging” and to promote low-cost generics and biosimilars.