On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.
In somewhat of a strange bedfellows situation, both PhRMA and GPhA support a proposed alternative to the FDA proposed labeling Rule called the “Expedited Agency Review” (EAR) for safety label changes.
Many changes proposed in this Rule are a result of the passage of the Medicare Modernization Act (MMA). In this post, we discuss a few issues where FDA is codifying provisions of the MMA for the first time (albeit they have been regulating directly from the statute since its passage in 2003).
Just to help you out a bit, here are some additional issues to pay attention to in the Proposed Rule. It may be time for your firm to comment, especially if you don’t like them.
The Center for Drug Evaluation and Research’s (CDER) Safety Research Interest Group, a subcommittee of Science Prioritization and Review Committee, is asking for organizations that may be conducting research and/or have interest in collaborating with the FDA in the 7 areas of interest identified by the Agency:
On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.
Continuing in a series of posts on the Proposed ANDAA/505(b)(2) Rule, we cover some new requirements for making proper certification and notice of such that are being proposed in the Rule.
Kent Johnson, former Deputy Director of the Office of Generic Drugs (OGD) and perhaps the biggest influence on the labeling review process since the passage of the Hatch-Waxman Act believes that the proposed labeling rule is bad for patients and pharmacists and will only cause confusion in the marketplace.
This edition of the Proposed Rule saga covers a few more interesting issues. The rule-which was 11 years in the making (longer than the final Hatch-Waxman rule on the patent and exclusivity provisions of the Act, which was10 years in the making) really tightens up some of the long-established practices of the Agency and explains why the FDA is taking the actions that it is. Makes for good reading, but make sure you have your toothpicks ready to prop open your eyes. We are just through page 120 of the 300+ pages.
On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.
