FDA was hoping to have the User Fee Bill passed and to begin work on publishing fees and the accompanying Federal Register Notices that must go out ahead of the September 30 expiration of the funding measures. Remember, FDA must have legislation in place in order to request the fees, collect the fees, and spend […]
The Office of Generic Drugs’ update to the Activities Report of the Generic Drug Program for June 2017 (here) lists 6 Refuse-to-Receive (RTR) actions, the lowest for any moth this fiscal year. As a matter of fact, it is the lowest number of RTR actions since early in the GDUFA days when, in May 2013, […]
To date, according to the FDA All Approvals report (here), so far this month there have been 54 recorded full approvals and 11 tentative approvals. Of course, we have today, July 31, not yet reported and there will be a few posting of approvals over the last 2-3 work days, but, unless there is a […]
The FDA today, in the Federal Register, announced a public workshop to be held on September 12, 2017 to discuss the use of real world data (RWD) and real world evidence (RWE) in its regulatory decision making process. The workshop, titled, “Developing a Framework for Regulatory Use of Real-World Evidence”, will be held in Washington […]
Today, OGD released an updated version of a Q&A document entitled, “Generic Drug User Fee Amendments of 2012: Questions and Answers: Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance”. This document provides FDA responses to many questions that have been raised by industry during the administration of GDUFA I. […]
The controversial rule that would “amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change” has shifted […]
Back in May 2016, I wrote a blog post (here) about a budgeting proposal put forth by Senator Joe Manchin of West Virginia that would have financed opioid treatment programs by a tax on the opioids themselves. This would eventually have placed higher purchase costs on the patients that needed the drugs. Well, now, there […]
On Tuesday July 18, 2017, the FDA held a public meeting entitled, “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access”. The meeting’s purpose was “intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help […]
The Manual of Policies and Procedures (MaPP) 4520.1 entitled Communicating Drug Approval Information, underwent revisions and the new revised MaPP was published today. While it’s current revision history notes the following change – “Decreased the time for webmaster to post change from three to two business days, for approved labeling for drug approvals”, […]
The USP is planning to revise their USP<1058> Analytical Instrument Qualification Chapter, August 01, 2017. The planned principal changes to USP<1058> are as follows: The revised USP chapter introduces the concept of a user-driven risk assessment to establish the level of integrated instrument qualification to demonstrate “fitness for purpose” of the instrument. In addition, the […]
