Degree of rigor may vary depending upon intended use of the data throughout a drug’s lifecycle, stakeholders say in comments on FDA’s first patient-focused drug development draft guidance; industry and advocates push for clarity on interactions to discuss patient experience studies with FDA staff and the promotional implications of such data.
The US FDA should clarify the level of rigor needed for collecting patient experience data based upon how that information will be used in a drug’s development, industry and advocacy groups tell the agency.
In comments on a June draft guidance on collecting comprehensive and representative input, stakeholders pressed FDA to better define the different types of regulatory decisions that could be supported by patient experience
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.
The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.
Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.
The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.
Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
