By Ramsey Baghdadi
At the end of the day on January 19, MannKind, the developer of the inhaled insulin therapy Afrezza, held a conference call. The firm was announcing they had just received...
Complete Transparency: Recent FDA Decisions Renew Calls For Making Complete Response Letters Public
Three major stakeholders in drug development—regulators, industry, and investors—say they want or could live with FDA complete response letters being made public. Why aren’t they, and will it happen in the current political environment?
More from Archive
More from Pink Sheet
• By
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
• By
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
• By
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.