In late September, the FDA announced that Tirzepatide is no longer in shortage. However, last week, the Outsourcing Facilities Association, an industry compounding group, initiated a lawsuit to challenge the FDA’s decision. As a result, the FDA has paused any enforcement or regulatory action and will reevaluate whether the drug is actually in shortage based […]
As of October 10, 2024, pursuant to section 319(a) of the Public Health Service Act (PHS Act), Department of Health and Human Services (DHHS) Secretary Becerra has determined that public health emergencies (PHEs) resulted from the devastation caused by hurricanes Helene and Milton. Because of the disruption to the availability of certain parenteral products, the […]
Though the FDA had indicated previously that it would not extend the deadline for full implementation of Drug Supply Chain Security Act (DSCSA) requirements, discretion appears to have become the better part of valor. On June 13, 2024, we posted a blog about waivers that would be available for certain small dispensers, and yesterday the FDA […]
Just a brief follow-up on our post of October 3rd (here) regarding the FDA’s determination that the drug shortage for Tirzepatide is over and the Agency’s “reminder” that, because the shortage has been resolved, 503B compounders should no longer be making the product. Well, a story by Brendan Pierson published by Reuters today (here), titled […]
The following chart represents the planned activities of the FDA to address certain OTC monographs over the next three years. The agency notes that while this list is aspirational, the list is not binding (what is with the FDA?). For those of you familiar with the old OTC monograph process, three years does not seem […]
Yesterday, the FDA published a “reminder” clarifying the status of compounded Tirzepatide now that the shortage for this GLP-1 product has been resolved. After confirming with the approved manufacturer of Tirzepatide that they now have sufficient supplies to meet current market demand, FDA is “reminding” both 503A and 503B compounders that, since the product is […]
Well, here we are at the end of Fiscal Year (FY) 2024 and, because we likely will not see official approval action totals for the last two months of the FY until sometime in November, we will take a stab at giving you the best estimate we can. For September, the unofficial approval actions look […]
On September 20, 2024, we posted a blog on the changes that are being contemplated by the FDA with issuance of the final M13A guidance (here). One of the major changes delineated in this guidance was elimination of the previous requirements for fed bioequivalence studies in over 850 different Product Specific Guidances (PSGs) for solid oral […]
It was on September 24, 1984 that Congress gave birth to the Drug Price Competition and Patent Term Restoration Act, also known today as Hatch-Waxman (at the time of the Act’s passage, it was called Waxman-Hatch because the Democrats were in power). For those of you who don’t remember or weren’t even born when Hatch-Waxman […]
Historically, and in most cases, industry knows that it will certainly be required to perform both fasting and fed bioequivalence studies on solid oral immediate-release products or it may have an option to seek a waiver of in-vivo bioequivalence requirements for BCS Class 1 drugs. However, a few days ago, the FDA published a listing of […]
