National Academies report argues that technologies cannot only be evaluated in the context of specific products, and FDA guidance should become both ‘more fluid and targeted.’
The US Food & Drug Administration should “consider more fluid and targeted guidance” to provide perspective advanced manufacturing technologies outside of individual product approvals, the National Academies of Science, Engineering & Medicine urges in a set of recommendations detailed in a new report.
The recommendation reflects concern that the Center for Drug Evaluation & Research’s “ability to foster innovation is fundamentally constrained by...
Ad spending changes in response to the FDA's new DTC policy could force the agency to shift the focus of its regulatory resources.
Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick and mortar chemists were also proposed.
FDA Commissioner Martin Makary also wrote in a JAMA article that the agency is not banning pharmaceutical advertising, but said industry has exploited weak enforcement.
