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The agency said sponsors intending to market multiple dose combinations should “avoid marketing excessive numbers of combinations whose components exert similar blood pressure effects.” Read More
CMS Administrator Seema Verma said value-based payment “is not a panacea…[but] it is an important part of our strategy to lower drug prices.” Read More
An audit by New York State Comptroller Thomas DiNapoli found that the state’s treatment programs didn’t adequately monitor patients with opioid use disorders to ensure they didn’t receive opioid prescriptions elsewhere. Read More
A federal lawsuit accuses Gilead of deliberately keeping a safer version of its HIV drug Tenofovir disoproxil fumarate (TDF) off the market until patent exclusivity ends for the original. Read More
The legislation would “increase prescription drug competition in U.S. markets, driving down prices and improving the quality of life for patients across the country,” the letter states. Read More
“Facilities using this processing technique to manufacture sterile drug products were a logical starting place because of the significant impacts on patient safety… Read More
Drug sponsors should assess the safety of non-genotoxic impurities (NGIs) in chemically synthesized drugs on a case-by-case basis, the EMA’s Committee for Medicinal Products for Human Use suggests in a draft reflection paper released for stakeholder comment. Read More
A California district judge dismissed a class action lawsuit against Rite Aid alleging that the drugstore giant pumped up patient copays for certain generic drugs — but left the door open for an amended complaint. Read More
Drug shortages have increased in both length and intensity over the past year, according to FDA officials who spoke on Tuesday at a public meeting on the issue in Washington, D.C. Read More