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…
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…
FDA requires PMAs for high-risk Class III medical devices and in certain cases, innovative technology where no predicate may be identified. The PMA submission and review process is more complex and takes much longer than a 510(k) submission. As one might imagine, the PMA submission requires considerable preparation and resources, due largely to the requirement…
PDG provides pharmaceutical strategy and development consulting expertise and serves as our clients’ regulatory voice at FDA. Whether you require a 505(b)(1) or 505(b)(2) NDA, PDG employs pharmaceutical industry professionals who routinely and successfully present client-proposed regulatory strategies to the Agency.
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…
PDG’s team of industry professionals has extensive experience in planning Pre-IND Meetings on our clients’ behalf (as well as other Type B Meetings).
Investigational New Drug Application – First, PDG will help you determine if an IND is required. FDA Guidance notes that there are times when it may not be clear if use of an FDA-regulated product might trigger an IND filing. However, FDA does not charge sponsors for Pre-IND meetings. PDG has orchestrated early stage strategies…
PDG designs and executes preclinical and clinical (Phases I-IV) programs associated with pharmaceutical product development and the securing of FDA approvals for both brand name and generic drug products. Our experienced and professional staff of pharmaceutical scientists and regulatory experts will help you navigate study design challenges across a wide variety of designs. These include,…
Pharmaceutical Development Programs – The importance of pharmaceutical industry experience at this critical juncture in the drug development program cannot be understated.
PDG navigates the complexities of the US pharmaceutical industry for clients through our strategic drug development services that include analysis of commercial potential during early stages of clinical development in parallel with regulatory planning.