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Jeff Gibbs was honored when The Food and Drug Law Institute (“FDLI”) awarded him with the 2013 Distinguished Service and Leadership Award. The award is given each year to as…
Hyman, Phelps & McNamara, P.C. is pleased to announce that James C. Shehan has joined the firm as Of Counsel. Previously, Mr. Shehan served for 19 years as Novo Nordisk…
Hyman, Phelps & McNamara, P.C. is pleased to announce that Kermit L. Jones, J.D., M.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Jones served…
For the third year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of “FDA Law” by the folks…
HPM and Virginia Tech are pleased to announce the availability of the first two DVDs of the VERSUS series that is being sponsored by the University. They provide an overview…
On January 18, 2011, the President issued a significant Order entitled a “Memorandum for the Heads of Executive Departments and Agencies.” The Memorandum directs “agencies with broad regulatory compliance and…
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Ricardo Carvajal has been named Director of the firm, and that Dara Katcher Levy has been named Of Counsel….
Hyman, Phelps & McNamara, P.C. is proud to announce that the inaugural “Best Law Firms” survey by U.S. News & World Report has ranked HP&M as a “Tier 1” law…
March 17, 2005 marked the 25th anniversary of the date the firm opened its doors for business. To commemorate the occasion, HPM employees celebrated with a formal dinner and dance…
Animals of all shapes, sizes, and species benefit from having access to animal drugs, veterinary biologics, and veterinary devices. Not surprisingly, the regulatory challenges for these products is just as…
Historically, individuals and companies that produce meat and poultry products for human consumption have been under the jurisdiction of the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS)….
In vitro diagnostic assays (IVDs) are some of the most complex regulated (and in some cases unregulated) devices on the market today. IVD manufacturers and laboratories running these tests need…
HPM advises clients on regulatory requirements applicable to food products, including conventional foods, medical foods, dietary supplements, food and color additives, food contact substances, and novel food ingredients. Labeling &…
Advancing knowledge of the functional characteristics and potentials of human cells and tissues has led to rapid growth in the research and development of therapeutic products derived from these materials….
Food contact materials are all materials and articles intended to come into contact with food, such as packaging liners and containers. These can be made from a variety of materials…
Product Approval The firm has developed a reputation for its expertise in new drug development. Working with scientific and medical experts, we assist companies in preparing and filing full new…
HPM advises companies on labeling, ingredient status, and packaging issues for both over-the-counter (OTC) drugs and cosmetics. With respect to OTC drugs, we assist companies with product claims, monograph issues,…
Navigating regulatory pathways Colors and colorants are often the unsung hero of product components. The right product color can evoke an emotional connection with a consumer or can give a…
For the fourth year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of FDA Law (both nationally and…
Federal and state regulation of compounded drug products has dramatically increased, leaving traps for the unwary and unprepared. Unprecedented regulation Since 2012, FDA and states have engaged in unprecedented regulation…
Dave Clissold speaking at FDLI conference
The firm was founded, as Hyman & Phelps, on St. Patrick’s Day in 1980. There were three founders: Paul Hyman, Jim Phelps, and Bob Dormer. They left a New York-based…
Jeff Gibbs will be speaking at Food and Drug Law Institute conference on Personalized Medicine – Promises & Challenges. AAAS Auditorium 1200 New York Avenue NW, 2nd Floor Washington, D.C….
Jeff Gibbs will be speaking on “A Look At IVD Regulation” at the Pharma MedDevice Conference Pennsylvania Convention Center Philadelphia, PA…
Josephine M. Torrente will be presenting: The New Drug Approval Process: New Drug Research and Development at the FDLI conference on Introduction to Food Law and Regulation L’Enfant Plaza Hotel…
Doug Farquhar will be moderating the break-out session on Unapproved Drugs; Drug Importation; Human Growth Hormone Cases at the 6th Annual FDLI Conference on Enforcement and Litigation L’Enfant Plaza Hotel…
This morning seminar will highlight the key current regulatory issues that can help device companies achieve success. The conference will integrate the new developments that directly affect device companies: the…
John Fleder and John Gilbert to testify before the United States Sentencing Commission on proposed changes to the Sentencing Guidelines for FDC Act and PDMA offenses.
Bob Dormer will be speaking at the New York State Bar Association Annual Meeting Marriott Marquis 1535 Broadway New York City, NY…
Brian Donato is one of the faculty for the National Trial Advocacy College, held at University of Virginia’s School of Law in Charlottesville….
Brian Donato will be speaking on “Agency Enforcement Powers” for the USC regulatory science course on medical products and the law….
Dave Clissold will be a speaker at the FDLI conference: FDA Implementation of the New Law The Food and Drug Administration Amendments Act of 2007 L’Enfant Plaza Hotel 480 L’Enfant…
ACI: Structuring, Negotiating and Managing Win-Win Pharma and Biotech Collaborative Agreements conference. The Westin New York at Times Square New York, NY Bob Dormer presenting: Making an Early Assessment of…
Kurt Karst will be a featured speaker for the Thompson Interactive audio conference on FDA “Revitalization” Legislation- Essential Changes You Must Know. 1:00 PM – 2:30 PM ET…
We help our clients navigate the complex issues surrounding the import and export of FDA-regulated products. Whether you are seeking advice before considering whether to import or export a product,…
ASQ: 18th FDC West Coast Conference New Dietary Supplement CGMP Final Rule Disney Paradise Pier Hotel Anaheim, CA Wes Siegner will be presenting….
CTFA Webinar: California Alert – Safe Cosmetics Act Potential Ingredient List Reviewed 12:30PM to 2:00PM EST Brian J. Donato will be conducting the Webinar. Click…
Stoel Rives LLP and the Association of Corporate Counsel Mountain West Chapter third annual Nutritional Law Symposium Thanksgiving Point Golf Club Lehi, Utah Wes Siegner will be moderating the panel…
Brian Donato presenting at CFTA Webinar on FDA Inspections of OTC Drug & Cosmetic Facilities: Your Rights & Obligations 12:30PM to 2:00PM EST Click here for more information….