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Printed By


Derrick Gingery

Executive Editor, Reg & Policy Insights, US

Washington, DC

Derrick focuses on the US FDA user fee programs, regulations and policy for new and generic drugs, biologics and biosimilars, advisory committee and other agency activities, as well as federal legislation and budget matters on Capitol Hill. He also hosts Pink Sheet's Pharma Regulatory Podcast. An award-winning journalist, Derrick has been a reporter for several community newspapers and a business journal. When not following FDA, Derrick is keeping close tabs on Indiana University basketball.

Latest From Derrick Gingery

Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

Generic Drugs Regional Comparisons

Rare Cancer Development Consortium Moving Toward Target Selection

An upcoming public meeting will include a look at platforms before the first targets are chosen.

Rare Diseases Research & Development

Stealth’s Elamipretide Gets US FDA Review, But Same Questions Linger

The Barth Syndrome candidate application will be reviewed by the FDA, but Stealth BioTherapeutics' CEO tells the Pink Sheet that the company still does not have clear guidance on how or whether it should gather additional clinical data.

Drug Review Rare Diseases

Quick And Flexible Vaccine Approval Must Include Postmarket Simplicity, US FDA’s Kaslow Says

After making the COVID-19 vaccines available, multiple presentations based on age and vaccination status created confusion that likely hindered uptake, said OVRR Director David Kaslow.

Vaccines Research & Development

Pink Sheet Podcast: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA

Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.

Post Market Regulation & Studies Advisory Committees

New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments

Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.

Generic Drugs Review Pathway
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