NORD Publishes Expanded Access FAQ
August 15, 2016
NORD has published a new guide to help people and caregivers living with rare diseases understand expanded access and how to access unapproved medicines. In the guide, NORD answers frequently asked questions including how to determine if you are eligible for expanded access, how to apply, and what you can expect throughout the application period and […]
NORD Issues Statement in Response to PDUFA VI Commitment Letter
July 21, 2016
On July 15, the Food and Drug Administration released the performance goals letter for the reauthorization of the Prescription Drug User Fee Act, also known as PDUFA VI. The PDUFA program is the agreement between the FDA and the pharmaceutical industry to pay user fees to facilitate the review of pharmaceutical products. PDUFA must be reauthorized […]
