CBI is holding its Fourth Edition Drug Pricing Transparency Congress on March 25-26, 2019 in Philadelphia, Pennsylvania. This program convenes stakeholders to discuss how the future of drug pricing transparency regulations will impact commercialization, reimbursement, pricing, and compliance practices. Given the novelty and complexity of …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …
Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce Allyson B. Mullen has become its newest Director. Allyson joined HPM in June 2013. Since that time, her years of service have made significant contributions to the firm and its clients. Prior to joining HPM, Allyson served …
The Food and Drug Law Institute’s (“FDLI”) Drug Quality and Security Act (“DQSA”) conference is just a few weeks away, and spaces are going fast! The conference will be held on November 15, 2017, in Washington, D.C. Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks an attorney to work with our drug development team. The attorney will assist our clients secure FDA approval for new drugs by leveraging our legal expertise of the approval …
On September 26, 2017, FDA combined and finalized two Draft Guidance documents first issued in 2011 that set forth the Agency’s approach to classifying products as “drugs” or “devices” under the FDC Act § 201. In doing so, FDA trimmed significant portions of both Draft …
The American Conference Institute’s (“ACI’s”) Food Law Regulation Boot Camp is slated to take place at the Wyndham Grand Chicago Riverfront in Chicago, Illinois from November 13-15, 2017. The conference is billed as a way to “[c]onnect the dots of food regulatory law and gain …
Hyman, Phelps & McNamara, P.C.’s Riëtte van Laack will be presenting on “Food Safety: Ingredient Preclearance/Intentional Components of Food” and on “Food Labeling: General Requirements” at the Introduction to U.S. Food Law and Regulation course, sponsored by the Food and Drug Law Institute on October 11-12, in Washington DC. …
Hyman, Phelps & McNamara, P.C.’s Mark I. Schwartz will be presenting on the Regulation of Biological Manufacturing at the Food and Drug Law Institute's (“FDLI’s”) Introduction to U.S. Biologics and Biosimilars Law and Regulation course, which is scheduled to take place from October 4-5, 2017 in Washington, …
Hyman, Phelps & McNamara, P.C.'s Jeffrey N. Gibbs has teamed up with MassMEDIC and Right Submission to bring you a free webinar, titled "FDA Medical Device Submissions – You’ve Got Legal Questions – We Have the Expert," that focuses on legal questions you might have relative to FDA product …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks an attorney to work with our drug development team. The attorney will assist our clients secure FDA approval for new drugs by leveraging our legal expertise of the approval …
On August 18, 2017, President Trump signed into law the Food and Drug Administration Reauthorization Act of 2017 (“FDARA”). In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDARA also makes several changes to the law concerning …
The American Conference Institute’s (“ACI’s”) 5th annual “Paragraph IV Disputes Master Symposium” is coming up! The conference will take place from October 2-3, 2017 at the InterContinental Chicago Magnificent Mile in Chicago, Illinois. ACI has put together an excellent program for conference attendees that include presentations from esteemed Judges …
On July 27, 2017, the Drug Information Association (DIA) journal, Therapeutic Innovation & Regulatory Science, published recommendations from the Clinical Trials Transformation Initiative (CTTI) Patient Groups & Clinical Trials (PGCT) Project team, of which HP&M Attorney James E. Valentine is a member, on the best …
The American Conference Institute’s (“ACI’s”) 5th annual “FDA Boot Camp: Devices Edition” conference is less than two weeks away! The conference will take place from July 26-28, 2017 in Chicago, Illinois. Jonette Foy, Ph.D., Associate Director for Policy (acting), CDRH, FDA will be presenting a keynote …
