FDA Guidance 2017

In its continued effort to ensure the availability of safe and effective drugs that improve health and well-being, the US Food and Drug Administration, more specifically The Center for Drug Evaluation and Research (CDER), has released a series of more than 100 new and updated draft guidance documents this year, says Dr Nicola Davies in her regular exclusive contribution to The Pharma Letter. Below is a brief outline of some of these documents and their importance.

Advertising:

The guidance document for this category covers the FDA’s stance for on-label and off-label communications in relation to manufacturer communications. While the document specifies that communications should be consistent with or related to FDA-approved labels, it omits some factors that may need reconsideration, such as proving that communication is misleading or false, which it is proposed should to be a fact-specific determination.1