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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

Pink Sheet Podcast: Merck’s Frazier Speaks Out, US FDA’s Hahn On Decisions, Operation Warp Speed, Worries About User Fee Goal Delays

Pink Sheet reporters and editor discuss Merck CEO Ken Frazier’s thoughts on racial inequity, FDA Commissioner’s explanation of coronavirus decision-making and Operation Warp Speed changes, and consider fears about the potential for user fee goal delays.

Coronavirus COVID-19 Leadership

Pediatric Study Plans For Coronavirus Therapies To Get Trans-Atlantic Streamlining

EMA and US FDA offer sponsors help in completing their pediatric study plan templates and identifying areas of overlap between the two agencies requirements.

Pediatrics Clinical Trials

FDA Asks For Input On Therapeutic Equivalence

The FDA wants to know if the second letter in its product equivalence ratings system is helpful and whether changes could make the information more user-friendly.

Regulation United States

House Committees Want BARDA Coronavirus Vaccine, Treatment Contract Info

Request for documents and a briefing is part of efforts to ensure federal programs are ‘protected from price gouging.’

Coronavirus COVID-19 Vaccines

US FDA Not Missing Assessment Goals, But Guidance Reminds That It’s Possible

New Q&A guidance also states that its near-term focus for resources will be on coronavirus and some other conditions.

Coronavirus COVID-19 Drug Review

'Orange Book' Changes? US FDA Soliciting Comments On TE Codes

The agency wants to know if the second letter in the product equivalence ratings system is helpful and whether changes could make the information more user-friendly.

FDA Generic Drugs
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