Day: July 7, 2016

A new draft Guidance Document on “Gifts to FDA” could be one of the strangest documents of its kind released by the Agency in its history. The document defines a “gift” to the FDA and then details the various rules that would govern the evaluation and acceptance of such gifts. Only the FDA Commissioner is … Read more

Last month, FDA held a public hearing to collect public opinions about enacting a new user fee for over-the-counter (OTC) drugs. The presenters at the hearing could be divided into three groups with distinct preferences. The FDA was the host of the hearing and a strong proponent of the OTC user fee giving several reasons why a user fee … Read more