By Allyson B. Mullen, Jeff N. Gibbs, McKenzie E. Cato* – Technological advances have resulted in Next Generation Sequencing (NGS) being used more and more frequently by diagnostic laboratories. NGS in vitro diagnostics (IVDs) present a new set of regulatory and technical challenges for FDA and …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks two attorneys to help with our fast-growing and robust practice. The ideal candidate for one position is an attorney with substantive expertise in medical device regulation. The other attorney is …
By Jennifer M. Thomas & John R. Fleder – On July 6, 2016, the Eighth Circuit upheld a district court ruling in United States v. DeCoster that imposed three-month prison sentences and $100,000 fines on Austin “Jack” and Peter Decoster, the owner and chief operating officer, …
By Kurt R. Karst – We like hunting down orphan drug clinical superiority precedents. And although it’s been said that “the thrill is in the chase, never in the capture” (by a Doctor Who character at least), we enjoy the capture just as much as the …
McKenzie E. Cato* and Allyson B. Mullen Many device companies struggle to ensure that the patients enrolled in their clinical studies are representative of the sex, age, race, and ethnic make-up of the U.S. population. In part, this task is difficult because device clinical studies are …
In recent years, the level of scrutiny of foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand for and dependence of Western countries on the supply of goods coming from those facilities. A recent webinar, International Pharmaceutical Supply Chain Imperiled …
By Karla L. Palmer – The Government Accountability Office (GAO) issued three reports during 2015 making eleven recommendations to the Drug Enforcement Administration (DEA) to more effectively perform their functions under the Controlled Substances Act (CSA) and DEA’s implementing regulations (see previous posts here and here). GAO now reports that, …
By Kurt R. Karst – First, FDA gets hit with a June 27th preemptive lawsuit over approval of generic versions of CRESTOR (rosuvastatin calcium) Tablets; and then, on June 28th, a second lawsuit is filed by Lannett Company Inc. and Lannett Holdings, Inc. (collectively “Lannett”) challenging FDA’s …
By Kurt R. Karst – Earlier this week, iPR Pharmaceuticals, Inc. (“iPR”), the owner of NDA 021366 for CRESTOR (rosuvastatin calcium) Tablets, 5 mg, 10 mg, 20 mg, and 40 mg, and AstraZeneca Pharmaceuticals LP (“AstraZeneca”), iPR’s agent, filed a Complaint in the U.S. District Court …
By Kurt R. Karst – Earlier this month, the U.S. District Court for the Eastern District of Virginia issued a Memorandum Opinion granting a Motion for Summary Judgment filed by the U.S. Patent and Trademark Office (“PTO”) and denying a Motion for Summary Judgment filed by …
By Allyson B. Mullen – On June 16, FDA issued the final guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.’” This final guidance replaces the draft guidance issued on April 23, 2013. Biocompatibility …
By Kurt R. Karst – For several years now, the Obama Administration’s annual budget requests (here, here, and here, for example) have included proposals to reduce to 7 years the current 12-year period of Reference Product Exclusivity (“RPE”) for biological products licensed under Section 351(a) of …
By Ricardo Carvajal – In an unusual “Early Alert,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) publicly took FDA to task for allegedly lacking “an efficient and effective food recall initiation process that helps ensure the safety of …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate with substantive experience in medical devices and other areas of food and drug law and regulation to assist with a growing practice. Strong verbal …
By Allyson B. Mullen – It is an open secret that at some point in every device company’s life one or more of its devices will likely be out of compliance with the Federal Food, Drug, and Cosmetic Act. That is because the regulatory scheme is …
