Device Trade Groups Offer Lukewarm Comments On Pre-RFD Draft
BIO and AdvaMed offered multiple concerns about a January US FDA draft guidance formalizing the pre-RFD process, including that the timeline is too long and that the recommended information may not land manufacturers a center designation.
You may also be interested in...
Brad Thompson says that phone calls used in current informal process help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.
On this week’s podcast, senior reporter Elizabeth Orr highlights the most exciting medical device technology coming down the pike as part of the US FDA’s Breakthrough Devices Program.
New research links the use of stents and balloons coated with the drug paclitaxel to an increased risk of lower-leg amputation shortly following surgery. The study was conducted by Greek researcher Konstantinos Katsanos, who previously found an increased mortality risk in paclitaxel-treated patients.