By Kurt R. Karst – It was just a few months ago that we posted on what might have been the first decision in a case involving a counterclaim seeking an order to correct or delete patent information from the Orange Book (and that does not …
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Year: 2014
- Court Orders Orange Book Patent Delisting in NUEDEXTA Infringement Litigation; But What’s It Good For?September 4th, 2014
- A Primer for Navigating the Murky, Drug-Infested Waters of Drug Diversion Administrative Revocation and Application HearingsSeptember 3rd, 2014
An article set to be published in the Albany Law Review in Spring 2015, titled “Drug Diversion Administrative Revocation and Application Hearings for Medical and Pharmacy Practitioners: A Primer for Navigating Murky, Drug-Infested Waters,” explores the increasingly complex and nuanced practice of administrative law before …
- The Generic Drug Labeling Carve-Out ScorecardSeptember 2nd, 2014
By Kurt R. Karst – With the recent litigation surrounding FDA’s approval of ANDAs for generic versions of PRECEDEX (dexmedetomidine HCl) Injection – which litigation has now moved on to Motions for Summary Judgment (see our updates here for the latest briefs) – we’ve had renewed …
- OGD Management Review Results in Forfeiture of Generic ACTONEL 180-Day Exclusivity EligibilitySeptember 1st, 2014
By Kurt R. Karst – The hope is that years from now (but hopefully not too many years), once the review and performance metrics FDA agreed to as part of the Generic Drug User Fee Amendments are in full effect and 10-month ANDA reviews (resulting in …
- GMA Announces GRAS InitiativeAugust 29th, 2014
By Ricardo Carvajal & Diane B. McColl – The Grocery Manufacturers Association ("GMA") announced an initiative designed to “improve the process and increase transparency for making Generally Recognized As Safe ("GRAS") determinations of ingredients added to food.” The initiative includes the following five elements: Development by independent …
- 340B Orphan Drug Exclusion Saga Continues; Court Says PhRMA Must Start OverAugust 27th, 2014
By Alan M. Kirschenbaum – We have reported previously (here and here) on PhRMA’s lawsuit challenging a HRSA regulation implementing the orphan drug exclusion that applies to certain types of covered entities under the 340B Drug Discount Program. To recap briefly, the rule had provided that …
- CDRH Seeks to Clarify UDI RequirementsAugust 27th, 2014
By Jennifer D. Newberger – On August 20, 2014, CDRH issued a guidance document, “Unique Device Identifier System: Frequently Asked Questions, Vol. 1.” The purpose, according to the guidance, is to “provide[] clarification of key provisions of the UDI Rule.” We previously posted on the UDI rule …
- FDA Puts Controls on Controlled Correspondence in the Agency’s Latest GDUFA OfferingAugust 27th, 2014
By Kurt R. Karst – This blogger’s oldest child started middle school this past week. Naturally, I was excited to get his impressions of the first day of school. “Good” was his initial comment – a now all too familiar one-word tween response with which I …
- Who can Recall what FDA’s Mandatory Recall Authority is? A U.S. District Court Could Not…August 27th, 2014
By David C. Gibbons – It is rare that we urge our readers to keep a copy of a court ruling or brief. A Brief that FDA filed on August 21, 2014 is an exception. Companies and others should read this brief and keep it close …
- Who Would Benefit from a Federal Standard of Identity for Honey?August 25th, 2014
By Riëtte van Laack – As previously discussed, since at least 2006, the U.S. honey bee industry has been trying to get FDA to adopt a standard of identity for honey. In 2006, the American Beekeeping Federation and honey industry groups petitioned FDA for a standard …
- Get Ready; Get Set…. DEA Publishes Final Rule Rescheduling HCPs: Affected Registrants Must Swallow a 45-Day Compliance WindowAugust 24th, 2014
By Karla L. Palmer – The U.S. Drug Enforcement Administration (“DEA”) published last Friday a Final Rule rescheduling hydrocodone combination products (“HCPs”) from Schedule III to Schedule II. We posted about the proposed rescheduling here (NPRM published February 27, 2014). There was little doubt that DEA …
- Final Rule on Branded Rx Drug Fee Treats All NDAs the Same, but IRS Might Consider a Special Rule for Pre-Hatch-Waxman Paper NDAsAugust 24th, 2014
By Alan M. Kirschenbaum – Beginning with CY 2011, Section 9008 of the Patient Protection and Affordable Care Act (“ACA”) has imposed an annual fee on manufacturers and importers of “branded prescription drugs.” The global 2014 fee for all manufacturers and importers is $3 billion, to …
- FDLI Conference on Food Safety and FSMA Just a Couple of Weeks AwayAugust 22nd, 2014
The Food and Drug Law Institute is sponsoring a conference titled "Food Safety: Latest FSMA Developments & Enforcement Actions in a Changing Business Climate," scheduled for September 9. The conference will feature a regulatory update by Michael Landa (Director of FDA/CFSAN), an exploration of the …
- In Generic PRECEDEX Litigation, Hospira Wins Temporary Restraining Order; Court Orders Recall of Generics, then BacktracksAugust 20th, 2014
By Kurt R. Karst – The pace of litigation concerning FDA’s approval of generic versions of Hospira, Inc.’s (“Hospira’s”) PRECEDEX (dexmedetomidine HCl) Injection, 100 mcg (base)/mL packaged in 200 mcg(base)/2 mL single-dose vials, has been anything but sedate. On the morning of August 18, 2014, there …
- FDA Issues Draft De Novo Guidance Incorporating FDASIA ModificationsAugust 19th, 2014
By Jennifer D. Newberger – On August 14, 2014, FDA issued a draft guidance titled, “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (draft guidance). The de novo review process, formally known as Evaluation of Automatic Class III Designation, is established by section 513(f)(2) of …