Saturday 1 September 2012

Was FDA Approval of Enzalutamide Too Fast

Enzalutamide has been approved by the FDA in an unprecedented time of only 3 months and shows how fast the FDA can work when pressurised to do so. But where is the pressure on the FDA to approve Enza;utamide coming from ? Why have the FDA approved Enzalutamide so quickly ? And who gets to profit from this decision ? The normal priority review time is 6 months and can take up to 12 months to review some drugs. Have the side effects of Enzalutamide been thoroughly investigated - unlikely in a 3 month review. The cardiotoxic side effects of Enzalutamide should be more thoroughly investigated before licensing this drug.

No comments:

Post a Comment