FDA is seeking input from an advisory committee on the use of a more data-driven model the agency is exploring to standardize quality assessment in generic drug reviews. Agency officials explain that model could help expedite the review of generic drugs to meet review goals under GDUFA II.
FDA will be getting feedback from advisors next month on plans for a more data-driven model approach to guiding and expediting the quality aspects of generic drug reviews.
FDA's Pharmaceutical Science and Clinical Pharmacology Committee will meet Sept. 20 on the agency's plans to liberate a quality review...
The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.
Sen. Bill Cassidy and HHS Secretary Robert F. Kennedy Jr. agree the disbanding of ACIP did not violate their agreement, but the perception that Kennedy is not following the spirit of the pledge could be more important long-term.
The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
