The government is currently funded through March 14th, 2025. Come Monday March 17th, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities. …
The rare pediatric disease priority review voucher program remains in its sunsetting state – the current authority only allows for granting of such vouchers if the drug was designated as a drug for a rare pediatric disease not later than December 20, 2024, and for …
Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. The Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) was caught in the crosshair once again. This time, however, the program, …
In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this blogger’s attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The rules were implemented to enhance patient safety protections via revised drug handling, packaging, …
We recently blogged about a new December 2024 draft guidance about accelerated approval (the “December 2024 draft guidance”). That post largely focused on endpoints as well as the broader context for when accelerated approval is appropriate. However, as we note in that post, the design, …
On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDA’s application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to …
This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these “lessons” will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. Although FDA has long taken the …
Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing. …
Since the induced infringement finding in GSK v. Teva, the generic industry has feared the death of the skinny label (admittedly stoked by alarmist headlines like my own, see Ding Dong is the Skinny Label (Effectively) Dead?). This is because, at a minimum, if a …
The Winter Solstice, signifying the shortest day of the year, was Saturday, December 21. Although the earliest sunset of the year was actually in early December, this day also marked another premature sunset – the beginning of the end of the rare pediatric disease priority …
We recently published the first part of our review of FDA’s draft guidance titled “Frequently Asked Questions – Developing Potential Cellular and Gene Therapy Products.” Questions and Answers Guidance (see previous coverage here). In this post we focus in on the draft guidance document’s chemistry, …
We learned earlier this week that an allision (a runner-up to Merriam-Webster’s 2024 Word of the Year, polarization) may be poised to occur—perhaps within a fortnight (another runner-up to Merriam-Webster’s 2024 Word of the Year thanks to Taylor Swift)—as Congress considers various pieces of healthcare …
On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. (See our post on this rule here.) …
On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. (See our post on this rule here.) …
On November 19, 2024, FDA released a draft guidance titled “Frequently Asked Questions – Developing Potential Cellular and Gene Therapy Products.” As much of the content of this draft guidance for cellular and gene therapy (“CGT”) products is articulated elsewhere, this document serves as a …
