Lachman Consultant Services Presents “Data Integrity: The Foundations of Metrics”

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a forum on Data Integrity. The forum will be held in the BALLROOM NAME, the same hotel as the ISPE Quality Metrics Summit, and will be followed by Q&A and a networking and cocktail reception.

Testosterone Warning: Use for Aging a No No! – Agency Update

The FDA issued an update to warnings about use of testosterone replacement products, indicating they are only approved for men with documented medical conditions. FDA stated, “[T]he benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”

371 Page Proposed Rule for Implementation of MMA ANDA and 505(b)(2) Provisions

Today, the FDA published a Proposed Rule (371 pages!) to amend its regulations and to implement Title XI of the Medicare Modernization Act (MMA). FDA is taking this step because it has been regulation directly from the statute since its passage, but also to facilitate compliance with and efficient enforcement of the FD&C Act, and to clarify and update these regulations based on recent court decisions and our practical experience implementing provisions related to the approval of 505(b)(2) applications and ANDAs.