The holidays are a season of joy, celebration, and time spent with family and friends. Of course, in recent decades, the holidays have also become synonymous with Black Friday sales, consumers fighting over popular products, and a general feeling of stress.
There is quite a bit of grey area, however, when it comes to the FDA’s authority over pharmaceutical compounding. While the federal FDA maintains plenary authority over traditional drug approvals, manufacturing, and sales at the interstate commercial level, pharmacy compounding generally remains subject only to State regulation generally due to its low-scale and localized effect.
Willful patent infringement does not necessarily result in enhanced damages or reimbursement of fees/costs. You can prove it but still the judge retains the discretion what to do (or not do) with that finding. This article explores a recent case where despite the willfulness finding, there was no extra awards.
We concentrate a large part of our work helping clients to solve legal problems when dealing with FDA compliance. Particularly, we help clients comply with the myriad of FDA statutes, regulations, and policies as they relate to drugs and devices.