SAN DIEGO – US Food and Drug Administration officials are finding that demanding dose-finding studies earlier in development is not as easy as it may appear in a policy document.
Project Optimus: Sponsors Register Concerns, Questions
Meeting requests related to the Oncology Center of Excellence’s new dose optimization approach are increasing, along with sponsor questions, prompting the US FDA to determine how to clarify its intentions.
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Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
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Pink Sheet infographic shows that while overall growth continues at the drugs and biologics centers, the US FDA still must add many employees to meet user fee-mandated hiring goals.
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Amid a push for new incentives, the US FDA’s Kerry Jo Lee, associate director for rare diseases in the Center for Drug Evaluation and Research’s Office of New Drugs, said in an interview with the Pink Sheet that the tools ultra-rare sponsors need already are available.
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Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
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Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.
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Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.