The date to comment is being extended to June 8, 2015, based on requests from the industry for more time to digest the Rule.
There are so many issues covered by the Proposed 505(b)(2) and ANDA Rule that we can fill a book with the explanations (and we almost have). But we are giving you the Readers Digest condensed version in these posts. Be certain to read the entire Proposed Rule and watch for comments on Regulations.gov to get an idea of which sections will provide more controversy than others.
There are certainly some interesting issues that are going to be codified if the Proposed Rule publishes in final the way it is currently written. Many of the proposals are being formalized into the regulations that represent the Agency’s past practice. Here are highlights of a few more of some of these important issues that should be of interest to our readers.
The good news is that April is starting out to have some promising numbers.
Today, we delve into the issues of court decisions impacting the 30-month stay. This area of the Rule is complex and dependent on the actions of the courts and the applicants.
Today is April 7, 2015, and the FDA Monthly Approvals list for March shows only 14 approvals and 4 ANDA Tentative Approvals.
The FDA has released a Draft Guidance entitled, “Development and Submission of Near Infrared Analytical Procedures – Guidance for Industry,” which covers the development, validation, and submission of NIR analytical methods.
In a Federal Register Notice scheduled to publish on Monday April 6th, FDA outlines a proposal to study the comparative advertising of prescription drug products.
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.
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.
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.
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.
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).