March of Dimes to FDA: Approve preterm birth drug
The March of Dimes medical director, Nancy Green, has testified before the FDA Reproductive Health Drugs Advisory Committee on the benefit of injectable progesterone for pregnant patients at risk of delivering premature infants. The drug, known as 17-P, or 17 alpha-hydroxyprogesterone (Gestiva), is currently under priority review by the FDA for the prevention of preterm birth in women with a history of early delivery.
March of Dimes to FDA: Approve preterm birth drug
The March of Dimes medical director, Nancy Green, has testified before the FDA Reproductive Health Drugs Advisory Committee on the benefit of injectable progesterone for pregnant patients at risk of delivering premature infants. The drug, known as 17-P, or 17 alpha-hydroxyprogesterone (Gestiva), is currently under priority review by the FDA for the prevention of preterm birth in women with a history of early delivery. Given as weekly injections during the second half of pregnancy, the long-acting form of progesterone was shown in a large study to reduce preterm birth rate by 33% compared with a control group. The March of Dimes estimates that almost 10,000 premature births in 2003 could have been prevented if all women eligible for the progesterone therapy had received it.
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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.
