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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

Vaccine Distribution Priorities To Rely On Governors, Not ACIP, HHS Secretary Azar Says

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.

Coronavirus COVID-19 Vaccines

An Oversupply Of COVID Antibody Treatments? Multiple Monoclonal Products Raise Potential For Errors

As distribution of Regeneron’s monoclonal antibody treatment for coronavirus begins, OWS officials worry about provider confusion with Lilly’s product due to differences in preparation and administration.

Coronavirus COVID-19 Safety

NIH-Licensed Patents Don’t Account For Substantial Drug Spending, GAO Finds

Far from energizing the ‘march-in’ debate, the GAO study finds limited potential impact, but a new antitrust clause in licensing agreements could give companies something to worry about even if specter of government pricing setting might not be a big concern. Even though GAO found that NIH-licensed products amount to about 1% of government drug spend, the issue isn’t likely to disappear because Biden will face continued pressure to act on drug pricing and a Republican Senate gives him few options.

Legal Issues Pricing Debate

Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity

The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.

Biosimilars FDA

BsUFA III: Sponsors Want Formal Meetings That Don’t Require Product Analytic Data

An early meeting option is needed so sponsors can discuss clinical trial endpoints and similar issues before analytic data is available, industry tells the US FDA.

Biosimilars User Fees

House Bills Would Close Orphan Exclusivity ‘Loophole’ And Thaw ‘Frozen’ Generic Labeling

US FDA-related legislation among the bills moving during the lame duck session of Congress.

Legislation Generic Drugs
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