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 suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
