Newsletter - July 7, 2016
FDA User Fee for OTC Drugs: Beware of What You Wish For.
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 is desperately needed. The consumer and physician groups formed the second group that liked the idea of higher FDA oversight of OTC drugs aided by the new user fee. Read More..
Gifts to FDA: FDA’s Strangest Guidance Document
A new draft Guidance Document on “Gifts to FDA” could be one of the strangest documents of its kind released by the Agency in its history.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 authorized to accept gifts on behalf of the Agency. A "gifts" means anything of monetary value given to FDA as an institution, including competitive grants awarded to FDA employees as part of their official duties. Read More..
FDA User Fee for OTC Drugs: Beware of What You Wish For.
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 is desperately needed. The consumer and physician groups formed the second group that liked the idea of higher FDA oversight of OTC drugs aided by the new user fee. Read More..
Gifts to FDA: FDA’s Strangest Guidance Document
A new draft Guidance Document on “Gifts to FDA” could be one of the strangest documents of its kind released by the Agency in its history.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 authorized to accept gifts on behalf of the Agency. A "gifts" means anything of monetary value given to FDA as an institution, including competitive grants awarded to FDA employees as part of their official duties. Read More..
