Return to the Proposed 505(b)(2) and ANDA Proposed Rule
After about a week or so off from reading on in the massive missive of the Proposed Rule, we are back cherry picking tidbits from the document that you may find interesting.
Here Comes the Flood – Amendments are the Next Mountain to Climb for OGD
The February 2015 Generic Drugs Activity Report looks much like the previous month’s report except for the number of amendments seen flying into the Office of Generic Drugs.
News Flash – OGD Leader to Go on Medical Leave
Dr. Kathleen (Cook) Uhl, OGD’s Director of the Office of Generic Drugs (OGD) will be going on an extended medical leave beginning on Monday, March 30, 2015.
Homeopathic Drugs Enforcement Policy to Undergo Review?
FDA is scheduling a Public Hearing on April 20 and 21, 2015 to obtain comments from stakeholders on the application of the enforcement policy related to homeopathic remedies. FDA indicated that they have not had a comprehensive review of the enforcement policies related to these products to reflect changes in the homeopathic market in over 25 years.
Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”
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.
Do We Have Your EAR Now?
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.
More on the 505(b)(2)/ANDA Proposed Rule
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).
Have You Finished Reading the Proposed 505(b)(2) / ANDA Rule? Yeah, Right!
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.
Looking for a Few Good Comments – FDA Identifies Needs for Drug Safety-Related Regulatory Science
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:
Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”
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.
