Scrip 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 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 Califf: We Don’t Need Much Help From Congress On Rare Diseases

The FDA commissioner also does not want the agency setting goals for rare disease treatment development.

Rare Diseases Gene Therapy

Accelerated Approval Now Starting Point For Gene Therapy Development, US FDA’s Marks Says

Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.

Gene Therapy Review Pathway

New Accelerated Approval Withdrawal Process More Streamlined, Marks Says

OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.

Review Pathway Post Market Regulation & Studies

Singulair’s Psychiatric AE Risks Still A Problem, But US FDA Has Limited Mitigation Options Remaining

Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.

Drug Safety Post Market Regulation & Studies

New US FDA Genetic Metabolic Adcomm Needs More Candidates

Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.

Advisory Committees Rare Diseases

US FDA’s Pazdur Wants Clinicians To Help Set Oncology Research Agenda

Oncology Center of Excellence director said clinical trial participation may increase if the research questions are ‘significant to answer.’

Cancer Clinical Trials
See All
UsernamePublicRestriction

Register