As previously noted here, we expected FDA’s enforcement activities and scrutiny of compounding pharmacies to increase after last year’s deadly outbreak of fungal meningitis tied to steroid injections compounded by the New England Compounding Center (“NECC”). Recently, FDA took steps to determine whether certain compounding pharmacies known to have produced high-risk sterile drug products in […]
FDA requested from Congress a budget of $4.7 billion for fiscal year (“FY”) 2014, which covers the period from October 1, 2013 through September 30, 2014. That amount represents an increase of $200 million from the $4.5 billion requested for FY 2013. According to FDA Commissioner Margaret Hamburg, M.D., FDA requires a larger budget because […]
On April 5, 2013, the Alliance for Natural Health USA (ANH) and Certified Board for Nutrition Specialists (CBNS) each filed comments opposing a Medicare reform regulation proposed by the Centers for Medicare & Medicaid Services (CMS). CMS proposed regulatory revisions to promote program efficiency, transparency, and burden reduction. See 78 Fed. Reg. 9216-01 (Feb. 2013). […]
On April 4, 2013, AbleChild.org filed an appeal with the Connecticut Freedom of Information Commission (FOIC) seeking release of Adam Lanza’s medical records held by the Connecticut Medical Examiner’s Office. That appeal, prepared by Emord & Associates and filed by the Heitke Law Office (Rhode Island), contests the Connecticut Medical Examiner’s refusal to disclose the […]
Dietary supplement companies should police their social media pages for disease claims from consumers and review how their website search fields operate to reduce the risk that FDA will regulate their products as drugs. As noted in a story by the Alliance for Natural Health, FDA recently issued two warning letters to companies based upon […]
Senator Dick Durbin (D-IL) plans to reintroduce a disastrous bill called the Dietary Supplement Labeling Act, which is aimed at further regulating the dietary supplement industry. The bill was originally introduced in 2011 as S. 1310. The bill requires food facilities that manufacture dietary supplements to submit the following information when registering with the FDA […]
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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