By Allyson B. Mullen – On January 15, FDA issued the draft guidance “Postmarket Management of Cybersecurity in Medical Devices.” This draft guidance is the postmarket counterpart to the draft premarket guidance that FDA released in 2013, which we previously posted on here and here. Without finalizing the …
By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons – The February 1st Federal Register contains CMS’s final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). The rule had been released for prepublication review on January 21. This rule, which has an effective date of …
By Allyson B. Mullen & Jeff N. Gibbs – Before the multiple feet of snow that the DC area recently received, CDRH had been creating its own storm of device guidance documents. One of the most recent ones is the final guidance “Submission and Review of …
By Melisa M. Moonan – FDA has granted stakeholders an additional 30 days to comment on its the December 31, 2015 draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').” The new deadline for comments is March 29, 2016. We previously commented on …
By Kurt R. Karst – Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or challenging FDA’s denial of New Chemical Entity (“NCE”) exclusivity for VASCEPA (icosapent ethyl) Capsules (NDA …
By Ricardo Carvajal – It’s getting hard to turn around without bumping into a Food Safety Modernization Act (FSMA) consultant. Perhaps it was inevitable, given the compliance dates that suddenly don’t seem so far away, the law’s many moving parts, and the mantra that FSMA is the most …
By Alan M. Kirschenbaum – Just ahead of a predicted snow storm in the Baltimore-Washington area, CMS yesterday issued a blizzard of 658 pages constituting its final regulation implementing changes to the Medicaid Drug Rebate Program. Although this is a final rule, CMS will be accepting comments …
By Ricardo Carvajal - On January 4, FDA denied the Weston A. Price Foundation’s citizen petition seeking revocation of the health claim for soy protein and coronary heart disease (CHD). As reported in a prior blog posting, the Foundation filed the citizen petition in 2008, and sued the …
By Riëtte van Laack – On January 15, 2016, the National Organic Program of USDA's Agricultural Marketing Service (NOP) announced the availability of guidance on substances that may be used in the post-harvest handling of organic products and in facility pest management. Under the Organic Food Production …
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2014) – Agreements Filed with the Federal Trade Commission under the Medicare …
By Jay W. Cormier & David B. Clissold – As we reported 18 months ago here, in July of 2014 the District Court for the District of Columbia granted summary judgment for what is now R.J. Reynolds Tobacco Holdings, Inc. in a lawsuit that alleged that the FDA …
By Allyson B. Mullen – On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule. The guidance is quick to …
By Melisa M. Moonan – It has come to our attention that FDA has initiated inspections at several hospitals in various parts of the country to assess compliance with User Facility Medical Device Reporting (MDR) obligations under section 519 of the Federal Food, Drug, and Cosmetic …
By James E. Valentine – On January 13, 2015, CDER’s Clinical Outcome Assessments Staff (formerly Study Endpoints and Labeling Development (SEALD)) announced the launch of Stage 1, or the pilot stage, of its Clinical Outcomes Assessment (COA) Compendium. A COA measures patients’ symptoms, overall mental state, or …
By Kurt R. Karst – A few months have passed since the appeals Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”) filed with the U.S. Court of Appeals for the District of Columbia Circuit after …
