Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
In making its announcement FDA Commissioner Robert Califf, M.D. stated that “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together…We implore health care professionals to heed these new warnings and more carefully and thoroughly…
The revised user fees will go into effect October 1, 2016 and remain in effect through the end of September 2017. It is important to note that not all fees will be reduced, and some will increase. Following is an excerpt of the story, recently published in Regulatory Focus describing key changes: ANDA ($70,480, down…
Issued on August 8, 2016, regulatory impact includes the following: FDA issued the original Deciding When to Submit a 510(k) for a Change to an Existing 53 Device (K97-1) on January 10, 1997 to provide guidance on this regulatory language This draft guidance preserves the basic format and content of the original, with updates to…