The degree of difficulty is tremendous for the first novel switch FDA approves, but it would provide a template others can follow. FDA’s interest in fostering innovative OTC switches could work in favor of proposals to make currently Rx ingredients indicated for a chronic condition available nonprescription.
The result of Pfizer Inc.’s quest for a potential Lipitor OTC switch would reverberate across the industry as other firms likely would follow with proposals to switch ingredients for chronic conditions FDA wants to target with OTCs.
FDA’s interest in fostering innovation in OTC switches could work in favor of a 10mg Lipitor switch or a proposal...
The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.
CMS Administrator Mehmet Oz said PBMs may deserve "one last chance" to fix the rebate system before federal regulations and legislation are enacted.
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.
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.
