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Regulatory and Policy News Developments Impacting Pharma
As the FDA sees another quarter with a net loss of employees in CDER and CBER, Pink Sheet editors discuss the potential impact and where it could manifest.
Pink Sheet editors discuss new information on the Commissioner’s National Priority Voucher Program, including the role of the center directors and the Commissioner’s National Priority Voucher Review Council in application reviews.
Pink Sheet editors discuss the average speed of FDA novel drug application reviews in 2025 and consider whether staffing departures and general upheaval throughout the year will impact times in 2026.
Pink Sheet editors discuss Richard Pazdur’s concerns about the Commissioner’s National Priority Voucher program and the idea that the FDA could release action packages for unapproved products in addition to complete response letters.
Pink Sheet editors and special guest Michael McCaughan discuss the legacy of long-time Oncology Center of Excellence Director Richard Pazdur, who retired from the FDA in December.
Manufacturers are responding to a convergence of factors, but plans will miss the rebate dollars they have relied on in the current pricing model.
The October 2024 reorganization that moved compliance functions back into the product centers has resulted in speedier issuance of biologics warning letters and an increase in drug manufacturing facility classifications, FDA compliance officials said.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.