The FDA has about 200 orphan drug designation requests that are pending review and that number has been steadily rising over the past five years. Recently, the FDA publicized its strategic plan to clear the bottleneck as part of its strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely[…]
In its effort to increase competition in the prescription drugs market and facilitate the entry of lower-cost alternatives, today the FDA published a list of branded drugs (based on the Orange Book Data Files) that have no listed patents or exclusivities and for which the agency has yet to approve a generic drug application. The[…]
On June 20, 2017, FDA issued the document Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Guidance for Industry DRAFT GUIDANCE. The goals of this guidance are as follows: • Update recommendations for applying and implementing part 11 requirements in the current environment of[…]
A clinical trial project manager (CTPM) is the nucleus of a clinical trial, therefore the success of each trial is heavily dependent on the performance of the CTPM. This recent article, 7 Breakthrough Behaviors For Clinical Research Project Managers, presents easy-to-implement strategies and tactics that will help CTPMs –[…]