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Related Practices Preparedness for an FDA inspection, assessing whether a customer complaint warrants a broader investigation or potential product recall, maintaining a quality system and ensuring ongoing staff compliance –…
Clinical laboratories face a complex regulatory landscape, including multiple federal and state regulators. HPM has significant experience representing clinical laboratories on a variety of legal, regulatory, and compliance issues, including…
HPM recognizes that the healthcare industry is made up of people working to improve the lives of patients. We routinely help healthcare providers navigate the laws, rules, and regulations that…
Related Practices Pharmacies are the last line of defense in DEA matters, and have increasingly come under the scrutiny of FDA and state boards given increased attention to drug supply…
FDA regulates over 20% of products sold at retail. In the past, FDA focused its compliance and enforcement efforts primarily on manufacturers and distributors of products, even though retailers are…
Transporters are an essential link in the supply chain. To mitigate hazards that can be introduced during transportation of food, the Sanitary Food Transportation Act of 2005 and the Food…
Ricardo Carvajal will be conducting a webinar on Reportable Food Registry. This is part of FDLI’s webinar series on Issues and Implementation of the Food and Drug Administration Amendments Act…
Bob Dormer will be presenting 505(b)(2) & Related Applications: EU, US and Canada at the RAPS Annual Conference & Exhibition Pennsylvania Convention Center Philadelphia, PA…
Earlier this week, the National Organization for Rare Disorders (“NORD”) held its annual gala here in Washington, D.C. recognizing achievements and advances in the area of rare (orphan) diseases. Of…
James Ellison is speaking on “Bolstering Trial Strategy in Litigation over AMP Calculations to Mitigate Exposure” at the ACI’s National Forum on Pharmaceutical Pricing Litigation. Carlton Hotel New York, NY…
Bob Dormer is a panelist for the session on “Pre-Conference Intensive Deep-Dive into the Orphan Drug Act: Demystifying the Designation Process and Discovering the Accompanying Incentives” at the ACI Orphan…
Frank Sasinowski will take part in Catholic Medical Mission Board (CMMB) meetings at the Vatican, including with the Pope, addressing the medical and pharmaceutical needs of people around the world….
Katie Bond is presenting “Doing Business in High-Risk Categories” at the Council for Responsible Nutrition/VIRGO Health & Nutrition….
Bob Dormer is speaking on “Hatch-Waxman Basics: Abbreviated Applications, Patents and Exclusivities” at the FDLI Introduction to Drug Law and Regulation conference. Hilton East Brunswick Hotel New Brunswick, NJ…
Frank Sasinowki is lecturing at Cornell University’s Sloan Program in Health Administration on “Drug Development and Health Care”. Ithaca, NY…
Jeff Shapiro is speaking on “Review of Recent Compliance Issues” at the AdvaMed/MTLI Advertising and Promotion Workshop. Washington Marriott Metro Center Hotel Washington, DC…
Frank Sasinowki, board member of the National Organization for Rare Disorders (“NORD”), is giving the keynote address for the Campaign Urging Research for Eosinophilic Disease’s (“CURED’s”) first research symposium on…
Jeff Gibbs is a Tutorial Instructor for “Personalized Medicine” session Panelist for “Regulatory, Ethical and Social Policy Issues in Personalized Medicine: Discovery to Clinic” session Panelist for “Regulatory Pitfalls in…
Jeff Shapiro will be speaking on “Fundamentals of FDA Regulatory Device Law” and on “Overview of Device Regulation” at ACI’s FDA Boot Camp Devices Edition. Chicago, IL…
Jeff Shapiro is speaking at the Orthopedic Surgical Manufacturer’s Association Fall Meeting on “Advertising and Promotion”. Arlington, VA…
Kurt Karst will be speaking on “Making the Case for An Rx to OTC Switch: Legal and Regulatory Considerations” at ACI’s Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs. The…
Kurt Karst is a co-speaker at ACI’s Maximizing Pharmaceutical Patent Lifecycles conference for the session: “Exclusivities and Forfeitures: New Developments, Controversies, and Related Concerns”…
Anne Walsh is a moderator for the session on “Trends and Priorities in Enforcement: Updates from HHS OIG and DOJ Officials” at the FDLI Advertising and Promotion Conference. Capitol Hilton…
Kurt Karst is speaking at the Workshop: “Hatch-Waxman and BPCIA 101 – A Primer on IP Basics and Regulatory Fundamentals” at ACI’s Paragraph IV Disputes conference. San Francisco, CA…
Kurt Karst is a co-presenter for the session on “Demystifying the Scope and Potential Impact of Proposed Legislation on Biosimilars to Enable You to Make Strategic Decisions Now” at the…
Diane McColl is speaking on “Oversight/Governance: Over an Increasingly Complex Food-scape” at the USP Science and Standards Symposium: Functional Foods and Dietary Supplements-Global Opportunities and Challenges. Boston Renaissance Waterfront Boston,…
Katie Bond presenting “Truth Stranger Than Fiction: Recent Developments in Dietary Supplement Litigation, Regulation and Truth in Advertising” at the Eighth Annual Nutrition Law Symposium….
Ricardo Carvajal is a panel member for “Compliance Challenges” and “Enforcement Hot Topics ” at the The Food, Drug & Cosmetic Division of the American Society for Quality 23rd West…
Wes Siegner is speaking on “FDA Update – Enforcement 2012: Things You Need To Know” at the Eighth Annual Nutrition Law Symposium. Thanksgiving Point Gardens 3900 North Thanksgiving Way Lehi,…
Jeff Gibbs is a panelist for the Round Table Discussion: “Best Practices in Working with FDA Reviewers to Secure Regulatory Approval” at the Clinical Affairs and Regulatory Approvals for Diagnostics…
Kurt Karst will conducting the PLI webinar on “Are You Ready to Enter the U.S. Biosimilars Pathway?” 1:00 to 2:00 pm EST…
Jeff Shapiro is conducting Thompson Interactive’s webinar on Changes to the FDA’s 510(k) Clearance Process Webinar 1:00 pm ET/12:00 pm CT/11:00 am MT/10:00 am PT Duration: 90 minutes…
Ricardo Carvajal is speaking on “Phosphorous Labeling in the U.S. – Regulatory Considerations” at the Dietary Phosphorus Consensus Conference. Honolulu, HI…
Kurt Karst will be speaking on “Orange Book Listings, De Listings and Related Challenges” at the ACI Hatch-Waxman Boot Camp. San Diego, CA…