Pink Sheet Podcast: US FDA Power Plays, Vaccine EUA Without The Sponsor, RBG’s Impact On Pharma
Pink Sheet reporter and editors examine the struggle over the FDA’s reputation, whether a coronavirus vaccine could be made available without sponsor cooperation, and the late Supreme Court Justice Ruth Bader Ginsburg’s legacy for pharma.
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One of US FDA’s most important publications ever, the Orange Book celebrates 40 years as the definitive guide to approved drug products and therapeutic equivalents. Even as the color has receded from the book itself, orange still generates appreciation from regulators and outside attorneys.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
CDC officials designing distribution plans worry some eligible for vaccination may wait for a better product to emerge.