OGD’s January Productivity Stats are In – What Do We See?
The Office of Generic Drugs (OGD) just released its January productivity numbers and there are some interesting observations to share.
Additional Tidbits from the Proposed ANDA / 505(b)(2) Rule and Oops! A Correction
Here are some more tidbits gleaned from the Proposed Rule, and a correction regarding a previous post.
Proposed ANDA and 505(b)(2) Rule Provides Codification of Long-Time Agency Practices
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….
More on the Proposed ANDA / 505(b)(2) Rule
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!
More Guidance on the Way from Office of Generic Drugs, and Other Nuggets
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.
Follow-up on the Proposed Rule on ANDA and 505(b)(2) Applications
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.
Trying Not to Compound the Problem – FDA Releases a Series of Guidance/ Policy Documents
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.
Snippets from the GPhA Annual Meeting Technical Committee Meeting
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.
Proposed Rule to Save FDA Postage!
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
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.
