No Longer Approvable or Not-approvable: What the FDA’s New Response to Drug Applications Really Means

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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:

  • State that the FDA will not approve the NDA or ANDA in its present form
  • Describe all specific deficiencies that the FDA has identified in the application, except when the agency determines the data submitted are inadequate to support approval. Deficiencies may be minor — for example, requiring labeling changes — or major, requiring additional clinical trials
  • Include a complete review of data in the NDA or ANDA and any amendments
  • If possible, recommend actions that may be taken to make the application eligible for approval.

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?

Find out in this 90-minute Encore presentation. 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.

Sign up your entire team to listen in and discover:

  • How the new rule changes the options drugmakers have in replying to the letters
  • Five strategic lessons on complete response letters drug companies can learn from biologic firms
  • Revisions to the regulations governing extensions to the review cycle after companies resubmit applications
  • The impact the complete response letters will have on media coverage and Wall Street analysts, and how drugmakers can use this to their advantage

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.

This presentation is a must for positions in brand and generic drug companies, including:
  • Communications professionals
  • Investor relations professionals
  • General and corporate counsel
  • Personnel new to the industry
  • Regulatory and legislative affairs professionals
  • R&D directors

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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Date: Sept. 1–19, 2008
Location: Your office or conference room (no need to travel!)
Time: Anytime

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