www.fdanews.com/articles/82628-fda-releases-guidance-on-noncontraceptive-estrogen-drug-products
FDA RELEASES GUIDANCE ON NONCONTRACEPTIVE ESTROGEN DRUG PRODUCTS
November 22, 2005
The FDA has released a final guidance to provide manufacturers with recommendations
on prescribing information and patient labeling for noncontraceptive estrogen
drug products for the treatment of vasomotor symptoms and vulvar and vaginal
atrophy symptoms.
The guidance includes specific prescribing information for healthcare providers,
as well as the recommended text for the patient information leaflet for noncontraceptive
estrogen drug products for the treatment of vasomotor symptoms and vulvar and
vaginal atrophy symptoms.
The final guidance updates draft guidances issued by the agency in October 1998,
Feberuary 2003 and February 2004.
To view the guidance, go to http://www.fda.gov/cder/guidance/6932dft.htm.