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JW Marriott San Francisco San Francisco, CA Jeff Gibbs presenting Regulation and Dissemination of Off-Label Information on May 16th. Overview of the FDA’s regulation of off-label promotion How can information…
Josephine Torrente will be speaking at FDLI Workshop: Introduction to Biotechnology Law and Regulation Workshop Focusing on Human Biologicals and Drugs The Madison Hotel 1177 Fifteenth Street, NW Washington, D.C….
Food Update 2007 – Food, Nutrition and Public Policy Amelia Island, GA April 21-24, 2007 Jeff Gibbs’ April 23rd presentation will be: How Viable is the Business Opportunity? Mr. Gibbs…
Doug Farquhar will be presenting at the FDLI 5th Annual FDLI Enforcement and Litigation Conference. Compliance Officers, Manufacturers of Unapproved Drugs and Devices, or Marketers? Who will be the next…
Dara Katcher will be presenting: Import & Export Requirements & International Issues at the FDLI: Introduction to Drug Law & Regulation Understanding How the Government Regulates the Drug Industry November…
What are the rules today, and how can we influence what they will look like tomorrow? A brave new world opened under the Biologics Price Competition and Innovation Act of…
HPM helps manufacturers and retailers understand FDA regulation of novel nicotine-containing products such as electronic nicotine delivery systems such as e-cigarettes, and traditional tobacco products including cigarettes, smokeless tobacco, cigars,…
The Organic Foods Production Act established the National Organic Program (NOP), a program run by the Agricultural Marketing Service of the USDA, to set uniform national standards for the production,…
HPM assists medical device manufacturers in understanding and managing all aspects of FDA’s regulation of medical device development, approval and clearance, manufacture and marketing. HPM lawyers have worked on a…
HPM has extensive experience advising clients on the regulation of controlled substances and precursor chemicals. At a time of growing concern about appropriate use of these highly regulated substances, our…
HPM provides advice to clients on FDA’s extensive regulatory authority over animal drug and food products, and FDA’s limited authority over devices, for both food and non-food animals. The firm…
Bob Dormer will be speaking at the American Conference Institute FDA Boot Camp. Omni Parker Hotel Boston, MA…
Compliance is critical. At best, compliant companies can avoid costly, time-consuming enforcement actions; at the least, compliance helps executives sleep better at night. HPM helps companies proactively meet federal and…
Bringing a product through the regulatory process requires knowing when to push back, when to go along, and when to change course. Our attorneys have helped bring many FDA-regulated products…
Keeping your products on the market depends on your ability to demonstrate to FDA that you manufacture your product according to the current good manufacturing practice (“cGMP”) standards for your…
HPM attorneys assist pharmaceutical, biologics, and medical device clients with the preparation and dissemination of promotional and advertising materials about their products. In a highly-regulated environment where what you say…
HPM’s attorneys can help you understand whether you have a problem and how to address it. Our attorneys have extensive experience conducting internal investigations within organizations large and small. Our…
Whether you are new to the industry or a well established player, HPM’s attorneys can help you navigate all aspects of the healthcare regulatory playing field. We can tackle your…
When it comes to the intricacies of the Hatch-Waxman and Biosimilars processes, HPM’s attorneys understand how important the details, especially timing, can be for your business. Our attorneys have extensive…
No one wants to be involved in a government investigation, let alone be the focus of an investigation. HPM attorneys have extensive experience helping companies and individuals navigate this difficult…
Enforcement HPM assists companies and individuals in responding to enforcement actions and threatened enforcement actions by state and federal prosecutors and regulators. Our attorneys have experience responding to a range…
HPM’s attorneys frequently assist companies in transactions of all sizes across all of our practice areas, including: Mergers and acquisitions; Partnering transactions; Licensing arrangements; Financings, including IPOs and follow-on offerings;…
Given the fast pace of technology and corresponding range of novel therapies under development today, you need an expert guide to help navigate the road to market. HPM frequently counsels…
Congress’ 2013 passage of Title II of the Drug Quality and Security Act’s Drug Supply Chain Security Act creates novel and significant obligations throughout the distribution supply chain. HPM’s attorneys…
The ability to deliver drug products efficiently and safely is a hallmark of the healthcare industry. This includes protection of the nation’s drug supply in the face of attempts to…
HPM has extensive experience advising clients on the regulation of bulk ingredients, including controlled substance bulk ingredients, from assistance with inspections and responding to FDA Form 483s and Warning Letters…
HPM provides agricultural producers with the necessary guidance to navigate an increasingly complex regulatory landscape. Our attorneys have the expertise needed to identify relevant FDA and USDA rules and regulations…
Partnering in advancing public health and patient care Your institution is dedicated to the service of the public good – from caring for the sick to conducting cutting edge research. …
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Product research and development can be full of unexpected twists and turns. The data expectations of the regulators is one of many potential stumbles, HPM has the experience to help…
Related Practices HPM’s attorneys advise chemical and other raw material suppliers on the FDA and USDA regulation of their products when used in human and animal foods, food contact articles,…
If you are developing a drug, biologic, or medical device, you are likely familiar with contract research organizations and institutional review boards. We help IRBs and CROs understand compliance issues….