ASHP reinforces its support for drug safety legislation
ASHP voiced its support this week for legislation that reauthorizes FDA prescription drug user fees. I
ASHP voiced its support this week for legislation that reauthorizes FDA prescription drug user fees. In an Aug. 28 letter to Sen. Edward Kennedy (D, Mass.), ASHP executive VP/CEO Henri R. Manasse Jr. wrote, "ASHP believes that maintaining the safety of our drug supply is a critical component of effective patient care." Manasse said the association supports several provisions in the legislation, including enabling the FDA to require the scrutiny of drugs under the Risk Evaluation and Mitigation Strategy (REMS), establishing a clinical trial registry and clinical trial results database for phase II-IV clinical trials, and increasing the oversight of direct-to-consumer advertising of specific prescription drugs.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
