AREA OF EXPERTISE
New Drug, Generic Drug, and Biosimilar Regulatory Policy
YEARS OF INDUSTRY EXPERIENCE
Pink Sheet’s Derrick Gingery has spent more than 11 years covering the prescription drug industry and has been a professional journalist for more than 23 years. During his time at the Pink Sheet, he has covered three user fee renewal cycles, FDA policy, and relevant legislation on Capitol Hill, as well as new and generic drug approvals and their impact on the broader landscape. He also hosts the Pink Sheet’s regulatory podcast, where he and his colleagues discuss the impact of FDA and industry news.
The US FDA's prescription drug, generic drug, and biosimilar user fee programs are expected to generate nearly $1.8bn in revenue in FY 2022 to help pay for marketing application reviews, manufacturing facility inspectins, and policy development. We have been closely reporting on the program renewal process, which takes place every five years, and is where industry and FDA representatives determine fee calculations, update application review timelines, and outline other policy changes with wide-ranging impact on developing and marketing drugs in the US. The agreement will then be turned into legislation that Congress will use to make additional changes at the agency.
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