The ANDA and 505(b)(2) Proposed Rule, that (due to its length) we like to call Moby Dick, addresses a plethora of issues of importance to the generic industry, and we are trying to tackle many of them in multiple posts. This is a continuation of that effort.
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.
Another month and another report of the approval actions of the Office of Generic Drugs (OGD) for our reader’s review
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.”
Like the old joke – How do you eat an elephant? One bite at a time! We are serving up some additional bites at the massive ANDA and 505(b)(2) Proposed Rule. I hope you enjoy your meal!
The Office of Generic Drugs (OGD) just released its January productivity numbers and there are some interesting observations to share.
Here are some more tidbits gleaned from the Proposed Rule, and a correction regarding a previous post.
There used to be two ways to trigger the 180-day market exclusivity provision for ANDA – a final court decision finding a patent not valid or not infringed or unenforceable and, of course, first commercial marketing of an ANDA product for which a PIV certification has been made after the 30-month stay….
As we continue our march through the 371 page document, as something piques our interest we will provide you with a bit of a summary along with some background. Here are today’s tidbits!
At today’s’ Science and Regulatory Advisory Committee meeting at the GPhA Annual meeting in Orlando, Florida (apologies to those in the mid-West and Northeast), Keith Flanagan, the Office of Generic Drugs’ (OGD) Regulatory Counsel provided a look into some guidance documents the industry can expect to see in short order.
We are slogging through the 371 page document and, as promised, here are a few more tidbits regarding changes that are being proposed in the new revised regulations.
Today, FDA released a set of 5 guidance documents designed to help compounders comply with new statutes, rules and regulations that can impact pharmacies, federal facilities, outsourcing facilities and physicians.
The GPhA Annual Meeting is being held in Miami this year. I’m sorry that I had to miss it (first time in over 20 years!) but the change in meeting dates conflicted with an already planned family trip. But the good news is that we are wired into some of the happenings behind the scenes and I have this to report.
This is a first in a series of posts that will outline some of the more interesting and unique changes that the FDA is making in its Proposed Rule issued last week
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.