Expanded Access Navigator offering directory of manufacturers' procedures and points of contact will depend upon industry cooperation, stakeholders at Reagan-Udall Foundation meeting conclude.
A Reagan-Udall Foundation proposal for an Expanded Access Navigator could make it easier for physicians and patients seeking access to unapproved drugs by providing a central repository of information about biopharma manufacturers' policies and points of contact.
However, the proposal requires strong support from manufacturers for it to work and many questions remain to be answered, such...
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.
