An award-winning journalist, Derrick has written extensively about user fee negotiations, the FDA budget, FDA travel restrictions and drug advertising compliance. He also was part of the Pink Sheet team covering FDA's first biosimilar advisory committee meetings.
When he's not following FDA, Derrick is keeping close tabs on Indiana Hoosiers basketball.
Latest From Derrick Gingery
The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.
Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.
Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.
Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
Industry feels that sufficient program management tools are in place, but a PDUFA VII negotiator says they need more time to mature.
New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.