The American Conference Institute’s (“ACI’s”) 11th annual “Paragraph IV Disputes” conference is right around the corner! The conference will take place from April 24-26, 2017 at the Conrad New York in New York, NY. ACI has put together an excellent program for conference attendees that includes presentations from esteemed …
Believe it or not, Hyman, Phelps & McNamara, P.C.’s FDA Law Blog turns 10 years old today (Monday, March 6, 2017). Where have all of the years gone? It seems like Tuesday, March 6, 2007 was just yesterday. That’s when we put up our initial …
The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 29th iteration, is back in New York at the Millennium Broadway Hotel on March 22-24, 2017. The conference is billed as the premier event to provide folks with a roadmap to navigate the …
The American Conference Institute (“ACI”), in collaboration with the Independent Cosmetic Manufacturers and Distributors (“ICMAD”), is holding the 4th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products on March 6-8, 2017 at the Millennium Broadway Hotel in New York City. Join …
The 21st Century Cures Act was signed into law on December 13, 2016. The Act addresses acceleration of medical product discovery, development, and delivery. Hyman, Phelps & McNamara, P.C. ("HP&M") will hold complimentary webinars on Thursday, January 12, 2017 from 12:00-1:30 PM (Eastern) and Wednesday, …
By Kurt R. Karst – Wikipedia (oh that font of knowledge and easy reference that it is for us bloggers) describes schizophrenia as a mental disorder characterized by, among other things, “failure to understand what is real.” That pretty much sums up FDA’s impressions of a September …
Earlier this week, we received notification from the editors of the American Bar Association (“ABA”) Journal announcing that Hyman, Phelps & McNamara, P.C.’s FDA Law Blog was selected to the 2016 (and 10th annual) ABA Blawg 100. The Blawg 100 is a list of the …
In a new article published by the American Bar Association in its Business Law Today November 2016 issue, Hyman, Phelps & McNamara, P.C.’s Andrew J. Hull discusses the state licensing issues present in corporate transactions involving pharmaceutical companies. In the article, entitled “A Practical Roadmap …
By Kurt R. Karst – We recently came across what we think is a pretty interesting FDA Exclusivity Letter Decision on 180-day exclusivity for generic versions of EDLUAR (zolpidem tartrate) Sublingual Tablets, 5 and 10 mg (NDA 021997; approved on March 13, 2009). The 180-day exclusivity …
By Riëtte van Laack – As we previously reported, in May 2016, FDA published a final rule amending the nutrition labeling regulations. Among other things, FDA defined dietary fiber as non-digestible soluble and insoluble carbohydrates (with three or more monomeric units), and lignin that are intrinsic …
By Jay W. Cormier – After three years of considering public comments on the draft, in last Wednesday's Federal Register, FDA issued its final FDA Guidance for Industry regarding Contract Manufacturing Arrangements for Drugs: Quality Agreements. With this Final Guidance, FDA has clarified its scope, specifically with …
By Karla L. Palmer – The Government Accountability Office (GAO) released a detailed Report last week addressing FDA’s efforts to regulate compounding since Congress’ passage of the Drug Quality and Security Act in November 2013. U.S. Gov’t. Accountability Office, GAO-17-64, FDA: FDA Has Taken Steps to …
By Serra J. Schlanger – The Department of Health & Human Services Office of Inspector General (“HHS OIG”) recently released its work plan for fiscal year 2017. The annual work plan summarizes what HHS OIG plans to review during the upcoming year as part of its …
By Riëtte van Laack – This case concerns small, high-powered magnet sets that users can arrange and rearrange in various geometric shapes. They were once a popular product, marketed as an adult desk toy and for making art works. The magnet sets consist of 100-200 magnets …
By Allyson B. Mullen & Jeffrey N. Gibbs – All this year, FDA had signaled it intended to finalize the guidance for Laboratory Developed Tests (LDTs). On Friday November 18, 2016, FDA abandoned the effort, stating that it will not provide the requisite 60-day notice to Congress …
