President Obama signed the Drug Quality and Security Act (“DQSA”) into law on November 27, 2013. The DQSA contained provisions concerning the oversight of human drug compounding. For instance, it removed provisions of section 503A of the federal Food, Drug, and Cosmetic Act (“FDCA”) that the U.S. Supreme Court previously held were unconstitutional, thereby ensuring […]
On behalf of the Certification Board for Nutrition Specialists (“CBNS”), Emord & Associates, P.C. submitted comments on proposed revisions to 42 C.F.R. § 482.28, which concerns food and dietetic services. The Centers for Medicare & Medicaid Services (“CMS”) agreed with CBNS’ comments and incorporated its suggestions into the final rule, 79 Fed. Reg. 27105 (May […]
Oral arguments concluded on Monday, April 21, 2014, in the POM v. Coke (Dkt. No. 12-761) case pending before the United States Supreme Court. Click here to read what experts had to say about the arguments. To recap, POM originally challenged Coke’s marketing for Minute Maid “Pomegranate Blueberry” fruit juice blend. POM filed a Lanham Act […]
In a recent article appearing on NutraIngredients-USA.com, Emord & Associates’ associate Bethany R. Kennedy comments on new dietary ingredient notifications for products that are approved drugs outside of the U.S. Click below to read the full text of the article at NutraIngredients-USA.com. Hank Schultz, “Companies must walk fine line when bringing a supplement to market […]
In a recent article appearing in Foodnavigator-USA.com, Emord & Associates’ principal Peter A. Arhangelsky predicts that a broad decision from the Supreme Court this year could limit food and dietary supplement manufacturers’ exposure to consumer suits in plaintiff-friendly states like California. To get there, however, the Court must hold that the FDA is the exclusive […]
Representative Mike Pompeo (R-KS) introduced legislation last Wednesday that would preempt state laws that require mandatory labeling of genetically modified foods. Currently, Maine and Connecticut have passed GMO labeling laws that are contingent upon other states approving such laws, but many other states are considering enacting GMO labeling laws. Pompeo’s bill, named the Safe and […]
On August 13th, the Food and Drug Administration (FDA) announced the availability of a revised draft guidance on medical foods entitled, “Draft Guidance for Industry: Frequently Asked Questions About Medical Foods, Second Edition.” FDA issued the draft guidance in response to confusion over the definition, labeling, and availability of medical foods, and to update FDA’s […]
Consumers harmed by a generic drug manufacturer’s failure to warn have no recourse thanks to a U.S. Supreme Court ruling. In 2004, Karen Bartlett took sulindac, a generic, prescription-only non-steroidal anti-inflammatory drug manufactured by Mutual Pharmaceutical, for her painful shoulder. A few weeks after Bartlett took the drug, she developed an acute case of toxic […]
Sarah Murnaghan, the 10-year old girl with end-stage cystic fibrosis who nearly died while waiting for a lung transplant, continues to recover after receiving two lung transplants and having surgery for partial diaphragm paralysis. Although she was at death’s door, Sarah almost did not receive a lung transplant because of an arbitrary and capricious rule […]
This month, the U.S. Supreme Court unanimously held that a naturally occurring, isolated segment of human DNA may not be patented because it is a product of nature. The Court also held, however, that complementary DNA (cDNA), which is synthetically created exons-only strands of nucleotides, may be patented because it is not naturally occurring. The […]
Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.
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