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.
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The FDA has released a Draft Guidance entitled, “Development and Submission of Near Infrared Analytical Procedures – Guidance for Industry,” which covers the development, validation, and submission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.