In an effort to provide a more consistent and neutral method to convey that it cannot approve a drug application in its current form, the FDA is replacing the approval and not-approvable letters with a complete response letter.
Following in the footsteps of its response to biologic applications that cannot be approved as is, no matter what the severity of the FDA’s concern with a drug application, the same letter will be issued informing sponsors of changes that must be made before an application can be approved.
The new complete response letters will:
How can you be certain you’ll know what to do to get your drug application on the right track once you’ve received a complete response letter?
Attorney and industry strategist Mark Senak will thoroughly explain the new complete response letter and how you can use it to your advantage. He will also explain the impact of the changes to the review cycles and show what drug firms can learn from biologic manufacturers in responding to the letters and announcing them.
Order today to listen in and discover:
Don’t waste time and millions of dollars trying to interpret the FDA’s complete response letter. You need to quickly prepare for this new response mechanism so you can deal with it and continue your efforts to get your drug to market.
Mark Senak is an attorney and communication professional with Fleishman-Hillard. He designs communications campaigns and serves as a senior strategist for pharmaceutical companies bringing new products to market. Mark’s goal is to align pre-approval communications with post-launch messaging, to reinforce regulatory compliance and maximize the reimbursement environment. He prepares pharmaceutical presentation teams before regulatory bodies and is highly experienced in crisis management on issues including pricing, company boycotts, clinical trial issues, serious adverse event communication, compulsory licensing issues and product labeling. Previously, Mark was the national director of health policy at Manning, Selvage & Lee, where he was responsible for providing strategic communications counsel on a wide range of public health and health policy issues and community relations. Mark has authored three books and numerous articles examining issues of law, health policy and HIV. He earned his law degree from Brooklyn Law School.
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