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Derrick Gingery

Senior Writer

Washington, DC
Senior writer Derrick Gingery has been reporting on regulatory issues for "The Pink Sheet" and "The Pink Sheet" Daily since 2010. Among his favorite topics are FDA's user fee programs, along with generic drug and biosimilar policy, but he also handles drug approval issues and general FDA news.

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

Generic Drugs: ‘Competitive’ Exclusivity Benefited Few Sponsors But Is Increasingly Popular

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.

Generic Drugs Intellectual Property

A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created

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.

User Fees Manufacturing

Adcomm Member Survey Shows Continued Support For Virtual Meetings After Pandemic

Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.

Advisory Committees Drug Review

Industry Willing To Let US FDA Go Slowly With Real-Time Review Expansion

Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.

User Fees Drug Safety

Bending PDUFA’s Cost Curve: PhRMA Looking For Sustainable Program Growth

Industry feels that sufficient program management tools are in place, but a PDUFA VII negotiator says they need more time to mature.

User Fees FDA

FDA Official Foresees Reduced Biosimilar Data Burden

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.

Biosimilars Drug Approval Standards
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