By Etan J. Yeshua – A regulation requiring restaurants in New York City to warn customers about menu items with high levels of sodium was set to take effect last week, but it is now the latest in a string of food labeling laws and regulations …
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Year: 2016
- New York City Sodium Rule Caught in Litigation is One of Many State and Federal Food Labeling Requirements Currently in LimboMarch 9th, 2016
- Amarin Announces a Proposed Settlement of its First Amendment Lawsuit Against FDA: Coming Full Circle in a New Era of the Regulation of Off-label PromotionMarch 8th, 2016
By David C. Gibbons & John R. Fleder – On March 8, 2016, Amarin Pharma, Inc. (“Amarin” or “the Company”) and FDA filed a proposed Stipulation And Order Of Settlement (“Proposed Settlement Order”) with Judge Paul Engelmayer in the U.S. District Court for the Southern District of …
- Fixing Erroneous FDA Guidance Can Take a Decade – and PersistenceMarch 7th, 2016
By Wes Siegner – In April 2005, FDA published guidance for industry on dietary supplement labeling, “A Dietary Supplement Labeling Guide.” As we wrote in 2009, an error in this guidance, stating that the term “dietary supplement” was not an acceptable statement of identity on its …
- Coming Soon to a Pharma Inspection Near You: The Program Alignment Group (PAG) PlanMarch 6th, 2016
By Mark I. Schwartz – There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how …
- Congress Puts Pressure on FDA and Proposes Incentives to Ramp Up Generic Drug ReviewsMarch 3rd, 2016
By Kurt R. Karst – The ongoing controversy over drug pricing has raised debate on many aspects of drug approval, and, in particular, on the approval of generic drugs. Over the past several months, there have been numerous letters from Members of Congress to FDA – …
- GAO Issues Report on Pediatric Voucher Program, Findings InconclusiveMarch 3rd, 2016
By Alexander J. Varond – On March 2, 2016, GAO released its report, “RARE DISEASES – Too Early to Gauge Effectiveness of FDA’s Pediatric Voucher Program.” While the report nicely summarizes the history of the program, it contains little new information. Highlights from the report include: FDA …
- FDA and Product Jurisdiction: Time for ReformsMarch 1st, 2016
FDA regulatory requirements for products are heavily influenced by the product’s classification. FDA has developed procedures for determining whether a product should be regulated as a drug, device, or biologic. Understanding FDA’s procedures for determining jurisdiction is essential for companies that are seeking to market …
- ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care ProductsMarch 1st, 2016
ACI is holding its 3rd Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products on March 7-9, 2016 at the Carlton Hotel in New York City. This is the first year ACI is partnering with the Independent Cosmetic Manufacturers and Distributors and the …
- HP&M’s John Fleder, Dara Katcher Levy, and James Valentine to Speak at DIA’s Marketing Pharmaceuticals 2016February 29th, 2016
DIA is holding its 27th annual Marketing Pharmaceuticals conference on Thursday and Friday, March 3-4, 2016, at the Bethesda North Marriott Hotel and Conference Center in Bethesda, MD. DIA is a not-for-profit, global organization dedicated to bringing health care product development professionals together in a …
- International Pharmaceutical Supply Chain Imperiled Like Never BeforeFebruary 29th, 2016
Over the past few years, the Food and Drug Administration has dramatically increased its inspections of foreign manufacturing facilities for Active Pharmaceutical Ingredients (APIs) and finished dosage form drugs, with potentially cataclysmic consequences for U.S. parent companies, distributors, and manufacturers relying on foreign APIs or …
- Booz Allen Issues Final Implementation Evaluation Report on CDRH Actions to Improve Device ReviewFebruary 29th, 2016
By Allyson B. Mullen – By In early February, Booz Allen Hamilton (“Booz Allen”) issued its Final Implementation Report assessing the actions taken by CDRH to address the firm’s earlier recommendations to improve the Center’s premarket review activities. We previously blogged on Booz Allen’s recommendations and …
- Another Court Weighs In on Whether Off-Label Promotion is Per Se Illegal; Jury Finds Both Defendants Not Guilty on All CountsFebruary 27th, 2016
By Jennifer D. Newberger – Judge Royce Lamberth, a Senior Judge in the United States District Court for the District of Columbia and sitting by designation in the United States District Court for the Western District of Texas, is no stranger to First Amendment cases involving …
- Just the Facts, Ma’am: OGD Director Uhl Provides the Lowdown on GDUFA ImplementationFebruary 25th, 2016
By Kurt R. Karst – Earlier this week at the Generic Pharmaceutical Association’s (“GPhA”) annual meeting in Orlando, Florida, Dr. Kathleen (“Cook”) Uhl, Director of the Office of Generic Drugs (“OGD”), gave the keynote address, providing the generic drug industry with a much-anticipated lowdown on FDA’s …
- Final Device Human Factors Guidance – Ch-Ch-Ch-Ch-Changes?February 23rd, 2016
By Melisa M. Moonan – After more than 600 comments and four and a half years since the draft guidance (“Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 21, 2011)) was published, FDA has released the final device human factors guidance, “Applying …
- Virginia Tech and HP&M Co-Sponsor Conference: Effective Documentation – Is Your Company Writing Itself Into Trouble? Learn to Write It Right!February 23rd, 2016
This 1-day conference, scheduled for Tuesday, May 3, 2016 in Arlington, Virginia, is for individuals who draft or review documentation relating to the quality of products regulated by FDA. Effective documentation (written communications/company records) is critical to the success of any company, most especially any …