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Showing posts with label Hormones. Show all posts
Showing posts with label Hormones. Show all posts
Sunday, September 22, 2013
Wednesday, August 14, 2013
It is a Myth That the FDA is Trying to Pull All Compounded Hormone Therapies off the Market; Estriol Can Be Used When Prescriber Has a Valid Investigational New Drug (IND) Application.
Myth: FDA wants all compounded hormone therapies off the market.
Fact: "We are not trying to pull all compounded hormone therapies off the market," says Silverman. "We believe that, like all traditionally compounded drugs, a woman should be able to get a compounded hormone therapy drug when her physician decides that it will best serve her specific medical needs. But we also want women to be informed and careful about choosing products that have not been proven safe and effective. And pharmacies cannot promote compounded drugs with false or misleading claims."
In addition, FDA has not approved any drug containing the hormone estriol. Pharmacies should not compound drugs containing estriol unless the prescriber has a valid investigational new drug (IND) application. INDs provide benefits that include allowing physicians to treat individual patients with drugs that are not FDA-approved, while also providing additional safeguards for patients.
quoted from here
Sunday, August 5, 2012
Report from Gynecologic Practice and the Americian Society for Reproductive Medicine Practice Committee
To read the August 2012 report on Compounded Bioidentical Menopausal Hormone Therapy
from the Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee click here.
from the Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee click here.
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