Physicians who prescribe hormones containing estriol have grown involved concerning the FDA’s so-called “abbreviated” Investigational New Drug (IND) software for estriol. The method will successfully ban most physicians from prescribing a medicine they take into account greatest for his or her sufferers.
The IND locations a major monetary burden on physicians, most notably by requiring them to submit functions to an Institutional Assessment Boards (IRB). Submitting obligatory documentation and contracting for a personal IRB can simply price between $10,000 and $25,000 and may take months.
The FDA’s new coverage threatens the entry of this necessary remedy for sufferers who depend on hormones containing estriol to alleviate the signs of menopause. It may drive them off remedy their medical doctors have deemed obligatory, and would both deny them remedy or topic them to the pointless expense and inconvenience of a brand new remedy regime.
Tens of millions of ladies have been prescribed estriol and have used it safely for many years.