By Ricardo Carvajal – FDA published a notice announcing the availability of a Draft Approach for Designating High-Risk Foods, and asking for comments and information to help the agency refine that approach. Designation of a food as a High-Risk Food (HRF) would trigger additional recordkeeping requirements intended …
By Jennifer D. Newberger – On February 5, 2014, CDRH released its 2014-2015 Strategic Priorities, in which it stated that the most important areas of focus over the next two years will be to “strengthen the clinical trials enterprise,” “strike the right balance between premarket and …
By Delia A. Deschaine & Alan M. Kirschenbaum – On January 31, 2014, the HHS Office of the Inspector General ("OIG") issued its Work Plan for FY 2014. The Work Plan sets forth OIG’s priorities for evaluations, inspections, and audits to be conducted in FY 2014 …
By Kurt R. Karst – A couple of weeks ago we announced a massive and unprecedented undertaking by FDA’s Office of Generic Drugs (“OGD”) to address an outpouring of concern about, among other things, a Manual of Policies and Procedures (“MAPP”) – MAPP 5200.3 – titled “Responding …
At the Food and Drug Law Institute’s (“FDLI’s”) 2014 Medical Device Conference – Key Legal and Regulatory Developments, which will take place in Washington, D.C. on February 27, 2014, top FDA officials will discuss their most significant recent activities and forecast upcoming medical device activities. …
By Kurt R. Karst – The Electronic Age has changed nearly every aspect of our daily lives, and the day-to-day operations of the U.S. Federal Government are no different. The government is no longer open for business from 9-5, but rather 24 hours a day by …
By Riëtte van Laack – On Friday, February 7, 2014, the FTC filed its long-awaited brief in the D.C. Circuit action concerning POM Wonderful LLC’s (“POM’s”) advertising for its pomegranate products (see our previous post here). Not surprising, the FTC asserts that POM’s ads were deceptive. First, …
By Riëtte van Laack – FDA published a proposed rule to implement the Sanitary Food Transportation Act of 2005 (“SFTA”) in the Federal Register on February 5. FDA also published Questions and Answers related to the sanitary transportation of human and animal food. Enacted in 2005, the …
By Jennifer D. Newberger & Alan M. Kirschenbaum – Last Friday, CMS issued a notice announcing the opening of registration for electronic Open Payments reporting under the physician payment sunshine provisions of the Affordable Care Act. (A previous post on the sunshine provisions and our memo …
By John A. Gilbert & Delia A. Deschaine – As previously reported here, late last year, CDER Director, Janet Woodcock issued a statement indicating FDA’s intent to recommend that DEA reclassify hydrocodone-combination products in Schedule II. (We note that scheduling recommendations are made to DEA by …
By Wes Siegner – On January 21 we posted on FDA’s unusual decision to reopen the comment period for the final guidance on INDs with respect to food and cosmetic research. Subsequently we learned that 60 university department heads submitted a comment to FDA’s Final IND …
By Larry K. Houck – The National Association of Boards of Pharmacy (“NABP”), along with a coalition of healthcare stakeholders, recently announced collaborative steps to address prescription drug abuse and practitioner compliance with federal and state corresponding responsibility requirements while ensuring that patients receive needed medical …
By William T. Koustas – The litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA may have come to an end on Tuesday, February 4th, when the United States Court of Appeals for the District of Columbia Circuit ruled against Regenerative, concluding that FDA has the authority …
By Larry K. Houck – Representative Bill Johnson (R-Ohio) introduced a second bill in Congress that seeks to curb abuse of dextromethorphan by teenagers. Johnson introduced the Preventing Abuse of Cough Treatments of 2014 Act (“PACT Act”) last week. The PACT Act, H.R. 3969, co-sponsored by …
By Jeffrey N. Wasserstein & Jennifer M. Thomas – Yesterday, the Department of Health and Human Services (HHS), announced a final rule (published in the Federal Register on February 6, 2014 – here) amending the Department’s Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, and the …
