The FDA Wants Consumers to Report Problems with MedWatch

FDA Invites Consumers to Report Problems to MedWatch

The U.S. Food and Drug Administration (FDA) has enhanced its MedWatch program and is actively asking consumers to report adverse events and serious safety issues with regard to FDA regulated products, whether they be medications, medical devices, or food products. The FDA encourages strongly consumers to use the MedWatch platform, first created in 1993, to report experiences with problematic products that seem to have unexpected side effects, injurious medical errors, therapeutic failures, issues with product quality, and any other safety hazards. [Read more…]

Upcoming FDA Public Hearing on Off-Label Drug and Device Use

Upcoming FDA Public Hearing on Off-Label Drug and Device Use

The U.S. Food and Drug Administration (FDA) has announced a public hearing forum to take place on November 9-10, 2016 with regard to the enforcement of rules relating to off-label drug and medical product use in the public health industry. The registration deadline to present at the hearing is October 19, 2016, and the deadline for written commentary after the hearing is January 9, 2017. [Read more…]