Combination Device and Drug/Biologic Submissions

Generally speaking, a combination product is composed of any combination of a device/drug, device/biologic, drug/biologic or combination of all three, including co-packaged products. Combination products are often confused with fixed combination dose (FCD) drug products, which are comprised of drug/drug combinations. Because PDG’s team of device consultants and pharmaceutical consultants possess industry expertise in the…

510(k) Submissions

PDG’s 510(k) compilation consists of a series of steps designed to ensure that CDRH accepts the filing. The first step is to determine (to the extent possible) that the 510(k) is the most appropriate regulatory pathway including whether traditional, special or abbreviated 510(k). This is followed by a data review of the device records, comparing…

Citizen Petitions

The staff at PDG is highly proficient in the compilation of targeted and effective Citizen Petitions addressed to FDA. PDG has participated in the compilation, submission and maintenance of multiple petitions. The topic areas have been many and varied including, for example, ANDA suitability petitions, requests for changes in drug labeling, generic drug review standards…