This free webinar will highlight the requirements, benefits and procedures for Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation and Accelerated Approval. The speakers will also discuss two newer programs, Regenerative Medicine Advanced Therapy (FDA guidance, Feb 2019) and Qualified Infectious Disease Program (FDA guidance, Jan 2018).
TORONTO (PRWEB) AUGUST 21, 2019
Accelerating the development of therapeutic products by pharmaceutical and biotechnology companies intended to treat serious conditions has been an interest of the public, legislators and the scientific community for many years. Responding to this interest, the US government has passed a number of laws intended to encourage the development of products for these indications, including the Prescription Drug User Fee Act of 1992 (PDUFA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and most recently, the 21st Century Cures Act of 2016.
Responding to these directives from Congress, the US Food and Drug Administration (FDA) has issued regulations and guidance documents to establish development programs designed to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies.
On Friday, September 20, 2019 at 12pm EDT (5pm BST/UK) join experts from Veristat, a clinical research organization (CRO) that specializes in partnering with emerging and small to mid-sized biotechnology firms, for this educational webinar. Examples will be included along with a live Q&A with the audience.
Participants will learn about the importance of establishing a therapeutic area as a serious condition with an unmet medical need for each of these programs and gain insights into:
- The requirements that must be met to qualify for each expedited regulatory pathway
- The benefits of the various pathways and the information needed to receive these designations or approvals
- Strategic elements to consider when choosing expedited pathway(s) to pursue at a given time
For more information or to register for this free event, visit Leveraging FDA’s Expedited Programs to Accelerate Product Development.
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