Global and local regulations
“FDA has been swinging the pendulum for a while now, and I think it will continue to become more accessible and predictable. However, that is at risk if FDA leadership changes.” —Chip Zimliki, regulatory affairs, Medtronic
“There are big changes coming in the E.U. regulatory scene. The notified bodies you have now will probably not be the ones you have in 2020.” —Frank Pokrop, Regulatory Affairs, BD Medical Technology (formerly Carefusion)
Alok Sharma says
In the year 2018, device industry must cohesively work more with Pharma companies to add value to the life of the patients. The disease and the disease patterns are changing & so the long term outcomes. Doctors / practitioners/ Companies & regulatory authorities must look at the side effects of post implantation of a device and prescribe medications so that long term outcomes of the patients are better with low side effects. Not all patients globally have an insurance Cover. Adipose tissue derived autologous Stem Cells treatment must get speedy approvals from regulatory authorities.