By Alexander J. Varond – On December 8, 2015, FDA approved two new therapies: Vonvendi (BLA 125577) for von Willebrand disease and Kanuma (NADA 141-453) for lysosomal acid lipase (LAL) deficiency. These approvals bring the number of new molecular entities and new therapeutic biological products approved this …
By Josephine M. Torrente & Etan J. Yeshua – In September, FDA proposed a significant limitation on the way drug sponsors can appeal FDA decisions, and yesterday Hyman, Phelps & McNamara, P.C. (HP&M) formally requested that the Agency reverse course. In a draft guidance document issued …
By Kurt R. Karst – Here’s something you don’t often see: FDA initiating procedures to suspend the approval of an ANDA because of an Agency determination that the Reference Listed Drug (“RLD”) was withdrawn for what the Agency determined were safety or effectiveness reasons. But on …
In November 2013, the Drug Quality and Security Act (“DQSA”) was signed into law in an effort to increase the quality of the United States drug supply. The law contains two separate acts: the Compounding Quality Act (Title I), and the Drug Supply Chain Security …
By Kurt R. Karst – Last Wednesday, November 25, 2015, after a long slog through the legislative process (see our previous post here), President Obama signed into law the Improving Regulatory Transparency for New Medical Therapies Act (H.R.639). (Unlike other bills, H.R.639 doesn’t have a sexy …
By Kurt R. Karst – In case you were under the impression that FDA’s interest in unapproved drug issues and the Agency’s broader Unapproved Drugs Initiative has been waning, or that the extent of FDA’s interest has merely been in sending out Warning Letters to companies …
By Kurt R. Karst – There are several important dates in the history of the Orange Book – FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations – some of which are the result of advancements in technology, and some of which occur (curiously) around the end …
By Kurt R. Karst – Earlier this week FDA finally released its Manual of Policies and Procedures (“MAPP”) on NDA Classification Codes (MAPP 5018.2) – formerly called “Chemistry Classification Codes.” The MAPP has been under development for quite some time . . . . and there’s …
By Jeffrey K. Shapiro – For more than 10 years, FDA has regulated human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) under 21 C.F.R. Part 1271. Under § 1271.10(a), if four criteria are met, the HCT/P qualifies for regulation exclusively under Part 1271. This status …
By Karla L. Palmer – FDA announced (here and here) earlier this week the availability of two draft guidances (here and here) for compounders using bulk substances under FDCA Sections 503A and 503B. FDA also published final guidance for compounders under Section 503A (see our previous post addressing that …
By Kurt R. Karst – Hatch-Waxman Patent Term Extension (“PTE”) disputes never get old for this blogger. There’s often some new twist for FDA or the U.S. Patent and Trademark Office (“PTO”) to consider, as shown in a recent PTE denial for a patent concerning the …
By Kurt R. Karst – Last week we posted on one of two bills recently introduced in Congress that continues a trend to push for (or reward) new product development by offering an incentive different from the standard grants of patent and non-patent marketing exclusivities (S. 2055, the …
By Kurt R. Karst – Last month we posted on a bill introduced in the U.S. Senate – S. 2041, the Promoting Life-Saving New Therapies for Neonates Act of 2015 – that would amend the FDC Act to add Section 530 to create a transferable “Neonatal …
By Kurt R. Karst – Predicting the future is a tricky business. Predictions don’t often pan out, even when most or all of the indicators prognosticators use say something will (or will not) happen. We have a pretty decent track record of guessing how a case …
By Jeffrey K. Shapiro – A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. The intended use of …
