Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Derrick Gingery

Senior Writer

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 the 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

US FDA's FY 2023 User Fees Finally Revealed

Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.

User Fees Review Pathway

New Name, Old Problems: US FDA’s Cell And Gene Therapy Office Still Facing Growth Challenges

The group will be called the Office of Therapeutic Products, but needs more people to handle its increasing workload.

Biologics FDA

US FDA Begins Implementing New User Fee Programs, But What About The Actual Fees?

Sponsors looking to file applications continue to wait for the new user fees to be announced, as details of the Split Real-Time Application Review (STAR) program, generic drug facility inspection readiness requirement and other changes are revealed.

User Fees Review Pathway

In-Person US FDA Meetings Returning? Agency Will Support Those Events At HQ

A workshop broadcast from White Oak was a shift from the fully virtual meetings held since the height of the COVID-19 pandemic and may be a step toward once again staging public events there.

Coronavirus COVID-19 FDA

After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?

Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.

User Fees Legislation

Next US FDA Generics Leader Must Have ‘Frank Conversations’ With Colleagues, Industry, Former OGD Director Says

Susan Rosencrance, who helped negotiate GDUFA III, will take over as acting director of the Office of Generic Drugs following Sally Choe’s departure on 8 October. Former OGD head Uhl says the director needs to be the ‘number one advocate for the generic drug program inside the agency.’

Generic Drugs Leadership
See All
UsernamePublicRestriction

Register