On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the...
PDG’s team of industry professionals has extensive experience in planning pre-investigational new drug (IND) Meetings on its clients’ behalf (as well as other Type B Meetings). This includes strategy, preparation, facilitation and post-meeting follow-up.
Based on PDG’s experience, the company believes that an effective pre-IND meeting is critical to a successful product development programme.
The pre-IND meeting is a strategic and relatively low-cost early determinant of the critical path for your product’s development. Such meetings are particularly valuable in the absence of sponsor experience, guidance, or other US Food and Drug Administration (FDA) information and standards. Regardless, the pre-IND meeting will help identify and resolve early development issues encountered specifically in the areas of toxicology, pharmacology and formulation / chemistry, maufacture, and control (CMC).
Pre-IND meetings increase chances for success
Meeting with FDA staff contributes to prevention of clinical holds and provides useful information in the compilation and submission of an IND.
Strategically planned and professionally facilitated pre-IND meetings increase the chances for success of your development programme. Despite the availability of guidance meant to assist sponsors, FDA meetings can be intimidating and unproductive. As such, many sponsors fail to get the most benefit from them.
Engaging a consultant such as PDG who routinely and successfully orchestrates Pre-IND meetings will help you avoid costly delays, build a solid relationship with the FDA, and secure the FDA’s early opinions and buy-in on your project.
The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review...