By Kurt R. Karst – Over the years, we’ve witnessed, learned of, and have even been part of several Orange Book “firsts.” There’s the first listing of patent information covering an old antibiotic drug product (here); the Orange Book note addressing a leap year new chemical …
By Kurt R. Karst – Last week, FDA filed a Notice of Appeal with the U.S. Court of Appeals for the District of Columbia Circuit appealing a September 9, 2016 Final Judgment and Order from DC District Court Judge Rudolph Contreras concerning Ferring Pharmaceuticals Inc.’s (“Ferring’s”) …
By Kurt R. Karst, John R. Fleder & Robert A. Dormer – The current FDA system to announce hotly contested generic drug approval decisions is broken. As we see it, FDA’s “system” pleases no one and does not appear to be legally mandated. Moreover, whatever advantage …
By James E. Valentine & Karla L. Palmer – There are a number of lists that are central to FDA’s regulatory framework for the regulation of pharmacy compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetics Act (FD&C Act). In recent posts, …
By James E. Valentine & Karla L. Palmer – We reported earlier this month that the Food and Drug Administration (FDA) amended its regulations to update the list of drugs that may not used in compounding under the exceptions set forth in sections 503A and 503B …
By James E. Valentine – In what can only be described as a success story, FDA’s Patient-Focused Drug Development (“PFDD”) initiative has opened the doors to hundreds of patients, caregivers, and other patient representatives to share their experiences with their diseases and conditions with FDA. This …
By James E. Valentine & David C. Clissold – Nearly two years after releasing its Notice of Proposed Rulemaking (“NPRM”), and with about 900 comments from the public to consider, the National Institutes of Health (“NIH”) has published its Final Rule on clinical trials registration and …
By Andrew J. Hull – There has been an interesting development in the ongoing prosecution of a slew of former officers and employees of the New England Compounding Center (NECC). As you may recall, the NECC was responsible for shipping allegedly contaminated compounded steroid epidural products nationwide, …
By James E. Valentine & Karla L. Palmer – On October 6, 2016, the Food and Drug Administration (FDA or the Agency) amended its regulations to update the list of drugs that may not used in compounding under the exceptions set forth in sections 503A and …
By Kurt R. Karst – A mere 1 year and 8 months after FDA’s February 6, 2015 publication of a Proposed Rule to implement certain provisions of the December 8, 2003 Medicare Modernization Act (“MMA”), Pub. L. No. 108-173, 117 Stat. 2066, and 12 years and …
By Alexander J. Varond – One day before the program’s sunset, President Obama signed a bill to temporarily reauthorize the rare pediatric disease priority review voucher program for 3 months. The program has had significant interest from industry, and the program’s extension on September 30 was …
By Anne K. Walsh & Andrew J. Hull – A problematic decision from the Ninth Circuit appears to impermissibly grant FDA authority to regulate the practice of medicine, and to further muddy the regulatory morass governing off-label use of products. We hope other courts recognize this …
By Alexander J. Varond – Late last week, the Senate voted unanimously to extend the rare pediatric disease voucher program until December 31, 2016. In doing so, it also voted to amend the definition of “rare pediatric disease” set forth in Section 529 of the Federal …
By Kurt R. Karst – Last Friday, FDA announced that the Agency licensed the fourth biosimilar biological product under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”): Amgen, Inc.’s (“Amgen’s”) AMJEVITA (adalimumab-atto) (BLA 761024), a biosimilar version of AbbVie Inc.’s (“AbbVie’s”) (BLA 125057) blockbuster …
By Alexander J. Varond – FDA’s rare pediatric disease priority review voucher program is set to expire on October 1. If this happens, FDA will no longer award pediatric vouchers to otherwise eligible sponsors. Expiration of the pediatric voucher program would mean the end (at least …
