I believe everyone likes seeing the progress of ANDA approval actions, and hold that as the primary measure of success of OGD. I know that has been the case ever since Hatch-Waxman was implemented in November of 1984. So I continue to track this metric very closely and at least through the morning of March […]
The FDA has published its guidance on Voluntary Recalls (here), revising the initial draft guidance issued April 24, 2019. The Agency notes that “[I]n addition to editorial changes made to improve clarity, changes from the draft to the final guidance include the addition of the terms correction and market withdrawal to the terminology section, the […]
As the combination products market continues to expand at a rapid pace, pharmaceutical and biotech companies need to be one step ahead as they bring new combination products and technologies to market. Manufacturers need to think about their products in a new way as they consider not just the drug itself, but also the design […]
Yesterday, the FDA issued its final guidance on the Pre-Launch Activities Importation Requests (PLAIR), a process that permits importation of unapproved NDA, ANDA and CDER-regulated BLA products into the United States in anticipation of imminent approval. The original draft guidance was issued on July 24, 2013. The FDA says that it considered comments received on […]
In an FDA announcement today titled Approved First Generic for Apokyn Injection Cartridges Requires Separately Packaged Pen (here), the Agency noted that this is the first generic approved without a delivery device. While I am aware of other FDA approvals where an off-the-shelf autoinjector was available to inject a prefilled syringe (that can be procured […]
The US Food and Drug Administration published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on February 23, 2022. After four years in the works and much debate about what the PR would include, we can finally read it for ourselves. The question in my mind was […]
In a twist that I am sure the FDA did not see coming, the landscape of FDA’s compounding position and the use of the Memorandum of Understanding (MOU) between the FDA and the States took a hit in a court decision back in “October 2020, [when] FDA was sued in the U.S. District Court for […]
In the prepublication edition of the Federal Register, the proposed rule on revisions to the Quality System Regulation was published today and may be found here. According to the notice, the Agency “is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with […]
The FDA is warning healthcare professionals of potential risks associated with compounded ketamine nasal spray (here). The Agency states that there is no approved ketamine nasal spray. Hey, wait a minute! (you might say); I could have sworn that I read about a ketamine nasal spray approval? Well, close! The product you may be thinking […]
The most popular program of each year’s AAM Annual Meeting is always the CEO unplugged session. Oftentimes there are significant disagreements between the different CEOs regarding strategy, but this year there was almost complete agreement on strategic issues, policy, the marketplace, and regulatory issues. The four panelists were Sven Dethlefs, Ph.D, Executive Vice President, North […]
