Download our Latest Paper: Help With BPCA, PREA, Initial Pediatric Study Plans (iPSP), Deferral and Waiver Requests

As pharmaceutical consultants engaged in the compilation and submission of marketing applications, we are frequently called upon by our clients to address all or part of their Best Pharmaceutical for Children Act (BPCA) and Pediatric Research Equity Act (PREA) needs. This paper is meant to serve as a review and primer for anyone at Pre-IND…

FDA Creates New Opportunity in Generic Drug Development; Public Meeting Held July 18

PDG recently reported that FDA took the unprecedented step of publishing a list of off-patent, and off-exclusivity branded drugs without approved generics. The agency intends to update this list every six months. At the same time, the agency implemented a new policy designed to “expedite the review of generic drug applications where competition is limited.”…

FDA Publishes List of 1000+ Class II Devices Exempt/Partially Exempt From 510(k) Requirements

Received from CDRH July 10, 2017: “Today’s Federal Register announces a list of 1,003 class II device types that the FDA believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. In an effort to decrease regulatory burdens on the medical…

Guidance for Industry

Help With BPCA, PREA, Initial Pediatric Study Plans (iPSP), Deferral and Waiver Requests

As pharmaceutical consultants engaged in the compilation and submission of marketing applications, we are frequently called upon by our clients to address all or part of their BPCA and PREA needs. This paper is meant to serve as a review and primer for anyone at the Pre-IND stage or who is confronted with the need…