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 Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval
Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.
US FDA Program Streamlining COVID-19 Treatment Development Still Working As Emergency Ends
Any program changes would not occur until after a thorough assessment, the agency said.
Sarepta’s DMD Gene Therapy Adcomm Likely To Focus On Dystrophin As A Surrogate Endpoint
Cellular, Tissue and Gene Therapies Advisory Committee will weigh whether the increase in dystrophin production seen with SRP-9001 is reasonably likely to predict clinical benefit in Duchenne muscular dystrophy, Sarepta says; agency had previously told the company a panel meeting would not be needed, but it reversed course late in the review.
Pink Sheet Podcast: Medicare Inflation Rebates And Negotiation, Leqembi Reimbursement, US FDA Gene Therapy Chief
Pink Sheet reporter and editors discuss the first round of mandated Medicare inflation rebates and new guidance on price negotiations, consider the VA’s decision to cover the Alzheimer’s drug Leqembi, and the US FDA continuing to search for a cell and gene therapy office leader.
US FDA Opens OTP Director Search Again
The new job notice offers a top salary, but also invites questions about the candidate pool attracted by the original solicitation.
Many US COVID-19 Guidances Set To Sunset With Emergency Declaration
But some, including some related to inspections and master protocols, will remain in effect to allow for revisions or a transition out of the pandemic posture.