Fda Law Blog

This blog covers topics of interest to Food and Drug Administration-regulated companies, fellow food and drug and health-care lawyers and regulatory personnel, as well as people just generally interested in FDA law. The blog provides timely updates on FDA enforcement actions, proposed rules, personnel changes, new and improved policies, along with related issues such as health-care fraud and abuse, drug and device reimbursement, HIPAA, and other topics of interest.

Author: Kurt R. Karst is an associate and Jeffrey N. Wasserstein is a partner at Hyman, Phelps & McNamara in Washington, D.C.

Blawg Related Categories: Administrative Law • Health Law • Tort Law • Product Liability Law • Associate • Partner

Recent Posts from FDA Law Blog

FDA Denies Galderma Petition on QI Act 30-Month Stay Issue
By Kurt R. Karst – In June, we reported on a citizen petition Galderma Laboratories L.P. (“Galderma”) submitted to FDA requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”)…
FDA’s Hearing on Social Media – More Questions, No Answers
By Dara Katcher Levy On November 12 and 13, FDA held a Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. The hearing represents FDA’s second attempt at gathering…
Proposed legislation to secure insurance coverage for certain medical foods could eliminate coverage for others
By A. Wes Siegner, Jr. and Ricardo Carvajal Sen. Kerry has introduced the Medical Foods Equity Act of 2009 with the goal of securing insurance coverage for certain medical foods. The legislation would secure coverage…
Hyman, Phelps & McNamara, P.C. Announces Two New Directors
Hyman, Phelps & McNamara, P.C. is very pleased to announce that J.P. Ellison and Kurt R. Karst have been named Directors of the firm. Mr. Ellison works primarily on civil and criminal litigation matters, including…
Center for Tobacco Products to offer training on eSubmitter
By David B. Clissold and Ricardo Carvajal The Center for Tobacco Products has scheduled a web-based training session on use of the eSubmitter program to electronically submit establishment registration and product listing information (see here).…
How do you solve a problem like Sidewiki? (our apologies to the Sound of Music)
By Jeffrey N. Wasserstein Your faithful bloggers at FDA Law Blog are, as you might expect, big fans of social media tools. After all, we blog, we tweet, and we are on LinkedIn, and Facebook…
Congress Asks FDA for Report on Generic Anti-Epileptic Drugs
By Kurt R. Karst – Buried in the Conference Report (Report No. 111-279) accompanying the recently-enacted Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (Public Law No. 111-80) is…
With or Without New Legal Authority, Agencies Move to Improve Food Traceability
By Ricardo Carvajal – FDA and USDA’s Food Safety Inspection Service (“FSIS”) announced a public meeting intended to “stimulate and focus a discussion about mechanisms to enhance product tracing systems for food” that will “help…
CPSC Holds Public Hearing on Draft Guidance Document on CPSIA Testing and Certification Requirements
By Michelle L. Butler – Yesterday, the Consumer Product Safety Commission (“CPSC” or “Commission”) held a public hearing on the draft guidance document proposed by the Commission staff regarding “Testing and Certification Requirements Under the…
District Court Denies Preliminary Injunction in a Case Challenging the Family Smoking Prevention and Tobacco Control Act
By Kurt R. Karst – The U.S. District Court for the Western District of Kentucky (Bowling Green Division) denied a Motion for Preliminary Injunction in a case concerning the Constitutionality of the recently enacted Family…