FDA to Extend Comment Period on Proposed 505(b)(2) and ANDA Rule
The date to comment is being extended to June 8, 2015, based on requests from the industry for more time to digest the Rule.
What? More on the Proposed Rule – Just Think How I Feel, but this is the Last Post on the Proposed 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.
The Proposed 505(b)(2) and ANDA Rule Continued!
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.
Update on March ANDA Approvals and Moving into April
The good news is that April is starting out to have some promising numbers.
Proposed Rule – Marching On
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.
If You Can Believe the FDA Monthly Approvals Page – The Corner May be Further Down the Road for OGD
Today is April 7, 2015, and the FDA Monthly Approvals list for March shows only 14 approvals and 4 ANDA Tentative Approvals.
A New FDA Draft Guidance Document for Near Infrared (NIR) Spectroscopy
The FDA has released a Draft Guidance entitled, “Development and Submission of Near Infrared Analytical Procedures – Guidance for Industry,” which covers the development, validation, and submission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.
Comparative Prescription Pricing – Office of Prescription Drug Promotion (OPDP) to Take a Look
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.
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.
