Law360 (April 25, 2019, 3:31 PM EDT) -- While a recent Law360 guest article addressing competitive generic therapies pointed out potential pitfalls, we believe that generic drug manufacturers can see considerable benefits from CGT with coordinated execution and thoughtful, strategic planning. But as with many opportunity areas, the devil is in the details, as CGT may also present challenges to applicants, particularly those who are not well-prepared or familiar with the statute.
What is CGT? The FDA Reauthorization Act of 2017 lets generic companies ask for expedited review and 180-day exclusivity for a CGT-designated product. That designation is provided to drugs where, at the time the abbreviated new drug...
Stay ahead of the curve
In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.
Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
Create custom alerts for specific article and case topics and so much more!