Choosing the Right Drug Name: How to Increase Your Chances for Approval
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Creating the name of a new drug in a market that already houses more than 22,000 drugs is no easy process. Nor is it cheap!
At a minimum, manufacturers must make certain their proposed drug name passes the worldwide trademark requirements, complies with standards not to imply a medical claim and meets standards for patient safety.
If the FDA rejects a name that a drug company has spent years and possibly millions of dollars creating, it can cost millions more in both lost sales and trashed marketing and sales materials … and then it’s back to the drawing board!
Now, the FDA has introduced a proposal to redevelop the drug-naming process. It held a meeting on June 5–6 with industry leaders to gather feedback on new plans, which resulted in very little positive feedback.
In fact, Carol Holquist, the director of the FDA’s Division of Medication Error Prevention and Technical Support, said that even if a firm follows the FDA’s proposed ideas to the hilt, it still wouldn’t guarantee approval.
Drug safety expert Susan Proulx will detail the industry’s concerns that were a result of the FDA’s June 5–6 meeting, and provide thoughts on how the proposal might change. She’ll also provide five best practices for what companies can do now to win FDA approval. In addition, Susan will outline the top seven reasons drug names get rejected.
Order today to listen in and discover:
- Details of the industry’s concerns as expressed in the June meeting
- Analysis of the review factors involved in the causes of medication errors related to trademarks
- Five best practices for what companies can do now to win FDA approval
- The role of the FDA’s Division of Medication Error Prevention (DMEDP) in evaluation of trademarks from the safety standpoint
- The current process that DMEDP uses to evaluate trademarks
- The role of DDMAC in the evaluation of trademarks from a promotional standpoint
- The top seven reasons drug names get rejected
- Current standing of the PDUFA IV legislation as it relates to proprietary name evaluation by pharmaceutical companies
Find out what industry concerns were exposed during last month’s meeting with the FDA — and what’s likely to happen as a result. PLUS, discover what you can do now to get your drug’s name approved by the FDA.