Top Regulatory Tips: Tips 7 & 8

Thursday, March 12, 2009

Part 4 of Top Regulatory Tips

View part: [ 1 | 2 | 3 | 4 | 5 ]

Previously:
« Tips 5 & 6

Next:
Tips 9 & 10 »


It's Thursday ... the weekend is getting closer by the second! Here are a couple tips for today:

Tip 7: Review regulatory issues in contracts carefully

Be careful not to lose control of regulatory choices. It may seem like a good idea to give the responsibility for your regulatory future to a large corporate partner, but in the long run giving control of regulatory away may mean your product gets shelved or delayed based on someone else's priorities. Having control of your regulatory destiny may seem daunting but it can ultimately be a large source of value. Don't give it away just because it seems overwelming.

Tip 8: Be careful with public statements

I once got a call from a company that had a FDA submission pending whose exeuctive had gone on a radio program and declared "we've talked with the FDA and they have no safety concerns about our product and we expect them to clear the application later this month." The FDA heard that one and was on the phone the same day with the VP of regulatory stating that this type of public statement could ultimately delay their clearance. It's illegal to predict when FDA might clear or approve your product. Even if this sort of statement is true, it's clearly not in the company's best interest to make and may ultimately be a rule breaker. Careful what you say. It's worth it to check out all public statements with your regulatory staff beforehand. An approved set of regulatory talking points can be an excellent way to handle this issue.

Tags: Best Practices, Enforcement, FDA, FDA 101

Part 4 of Top Regulatory Tips

View part: [ 1 | 2 | 3 | 4 | 5 ]

Previously:
« Tips 5 & 6

Next:
Tips 9 & 10 »


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Steve Gutman
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