.png){kind=logo}
INNOVATIVE PRODUCTS / FDA
Innovation.
With direction.
A strategy for
what comes next.
Assess product potential. Identify an appropriate FDA pathway. Move innovation
forward.
Assess Explore Navigate Plan
01 / INNOVATIVE PRODUCTS
Start with
the potential.
A strategy shaped around your product.
01 / FDA
Innovative Product Assessment
Innovation drives medical and pharmaceutical advancement. We help assess your product’s potential and the
regulatory questions raised by improvements in safety, effectiveness, diagnosis, treatment, or patient care.
02 / INNOVATIVE PRODUCTS
Evaluate
breakthrough potential.
Understand the evidence and the applicable program.
01 / FDA
Breakthrough Considerations
A potential improvement for a serious or life-threatening condition may warrant exploring an FDA breakthrough
program. We help assess the supporting evidence and the program relevant to your product. Eligibility and
evidence requirements depend on the product and pathway.
03 / INNOVATIVE PRODUCTS
Navigate
what’s novel.
Novel products need a carefully considered route.
01 / FDA
Novel Products & Pathways
Products that differ substantially from previously authorized products can raise complex classification and
development questions. We help identify appropriate FDA pathways and explore whether an expedited program
may be relevant. A novel product is not automatically eligible for an expedited program.
04 / INNOVATIVE PRODUCTS
Build
a clear strategy.
Move innovation forward responsibly and efficiently.
01 / FDA
Regulatory Strategy
Our consultants help connect product potential, evidence, and the appropriate FDA pathway into a clear strategy.
The aim is to support innovation that can improve patient care and advance public health.
CONTACT US
Plan your
next step.
Discuss your product, regulatory pathway, and U.S. market needs with Provision Consulting Group.