Day: March 29, 2018

In its latest Guidance Document and announcement for the current policy for compounding pharmacies, FDA emphasizes that the law supports only compounding drugs for which there is a clearly defined “clinical need” and not where compounded versions of approved drugs are created to make cheaper treatments for patients. The policy specifically applies to the 503B … Read more

It is assumed that greater transparency would discourage undesirable activities but experience shows that the disclosing parties become more careful and use reporting loopholes to their advantage. A review of the California law that requires companies to disclose exorbitant drug price increases seems to show little effect, if any, of such disclosure on such increases. … Read more