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 …
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 …
The FDA Law Blog is pleased to announce the release of the FDA Deskbook, prepared by the attorneys at Hyman, Phelps & McNamara, P.C., the same authors who provide the expertise and analysis contained in this blog. The FDA Deskbook is a complete resource on …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the publication of its FDA Deskbook, incorporating more than a century of experience of HP&M’s attorneys from positions in the government and regulated industry. The FDA Deskbook provides a comprehensive resource that details the ins-and-outs …
On March 31, 2016, from 10:00 AM – 12:30 PM, the American University Washington College of Law (Washington, D.C.) will hold a symposium to discuss recent developments in off-label promotion, including the recent Amarin case (see our previous post here). The symposium, titled “Drug Promotion …
DIA is holding its 27th annual Marketing Pharmaceuticals conference on Thursday and Friday, March 3-4, 2016, at the Bethesda North Marriott Hotel and Conference Center in Bethesda, MD. DIA is a not-for-profit, global organization dedicated to bringing health care product development professionals together in a …
