Miscellaneous

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 …

Week 52 is often more laid back than any of the other 51 weeks in the calendar year. It offers us a chance to sift through and clean out the office in preparation for yet another busy year.  But it’s also a chance for this …

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 …

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 …

Hyman, Phelps & McNamara, P.C. ("HP&M") has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers …

In May, HP&M released a comprehensive FDA Deskbook, prepared by the same authors who provide the expertise and analysis contained in this blog.  Since then, the Deskbook has been well-received by individuals at companies of all sizes and sophistication. HP&M has secured a 25% discount …

By Jenifer R. Stach – How often do we hear this familiar story: I submitted a request to FDA under the Freedom of Information Act (FOIA) but years later I have received no responsive records? Recently, two groups challenged FDA’s delays in processing FOIA requests. The court’s …

  In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. Furthermore, increased enforcement aimed at the medical …

By Jay W. Cormier – It is no surprise that in a presidential election year that every piece of legislation in Washington gets an extra dose of political theater. Federal funding for Zika virus research is no exception.  The President and the NIH have been asking …

Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Serra J. Schlanger has joined the firm as an Associate. Ms. Schlanger assists clients with FDA regulatory strategy, compliance matters, and enforcement issues.  She has specific expertise with regard to federal and state health …

The American Conference Institute (“ACI”) will hold the Second Annual Legal, Regulatory and Compliance Forum on Animal Health: Veterinary Drugs, Therapeutics, and Animal Food on September 13-15, 2016, in New York City at The Carlton Hotel.  This forum will help attendees make sense of the legal …

The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 28th iteration, is slated to take place at the Omni Parker House in Boston, Massachusetts from September 22-23, 2016. The conference is billed as the premier event to provide folks with a roadmap …

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 …

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 …

  In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. With the international pharmaceutical supply chain imperiled …