Empower Pharmacy markets itself as a well-meaning rival to Big Pharma - one that seeks to democratize medicine by making ...

Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

For both foods and drugs, most foreign inspections were pre-announced; the agency also re-emphasized its ban on inspectors ...

Vinay Prasad, a critic of the Food and Drug Administration, has been tapped as the agency’s top regulator of vaccines, gene ...

President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of ...

Serious consideration must be given by FDA as to whether the agency has the authority to dispatch the self-affirmed Generally ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

Recent FDA alert reveals concerning side effects of topical finasteride hair treatments that may persist long after stopping ...

The US Food and Drug Administration plans to phase out the use of petroleum-based synthetic dyes in the US food supply due to ...

The executive order adds on to Trump’s planned tariffs on pharmaceuticals in his overall strategy to onshore production of ...