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…against nonconforming facilities. Threats posed by bribery and corruption. Anti-corruption compliance issues from U.S. and Asian perspectives. “War stories” from recent investigations. When Wednesday, September 14, 2016 1:30 p.m. –…
…Honor. I believe it does. But that is the sum of my argument, unless the court has any further questions. THE COURT: No. You’ve been very helpful. I’m glad to…
…against nonconforming facilities. Threats posed by bribery and corruption. Anti-corruption compliance issues from U.S. and Asian perspectives. “War stories” from recent investigations. When Wednesday, September 14, 2016 1:30 p.m. –…
…entities. Comments on both Notices are due by November 19. HRSA says it will consider the comments in formulating its proposed regulations. There will be another opportunity to comment on…
…list. Like all things Hatch-Waxman, it is quite complicated and takes a lot of time to figure out. Imagine, if you will, coming across a cache of 5,000-piece puzzles in…
…Principal Deputy Commissioner Joshua Sharfstein set out their agencies’ priorities for regulation of dietary supplements. For FTC, a continuing priority is advertising substantiation. Mr. Vladeck, in his speech, stressed that it is…
…to regulated industry, and to complain about the reluctance of industry to utilize these cutting-edge tools because of the lack of clarity surrounding industry’s obligations. Several companies and trade associations…
…in August 2007, FDA approved the first generic version of FAMVIR under ANDA No. 77-487 and granted 180-day exclusivity.) FDA first approved FAMVIR under NDA No. 20-363 in June 1994. …
…available at an additional cost. If you are interested in taking advantage ofthis special rate, please contact ACI’s Lisa J. Piccolo at L.Piccolo@americanconference.com. The second conference is the Center for…
…runs the blog DrugWonks.com. In his latest post on this issue, Mr. Pitts pillories Rep. DeLauro for her press release and letter. Mr. Pitts’ colleague, Robert Goldberg, also recently posted…
The accolades keep rolling on in . . . . USPharmD has named the FDA Law Blog one of the “Top 50 Medical Ethics Blogs.” According to them, we will…
…boy!” Last week, RNCentral.com issued its “100 Best Health Care Policy Blogs.” FDA Law Blog joins some other usual suspects in the “Drugs/Pharma” category, including Pharmalot and Eye on FDA. …
Kurt R. Karst of Hyman, Phelps & McNamara, P.C. (and co-chief blogger of FDALawBlog.net) will be speaking at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes, October…
On July 1, 2008, ConsumerLab.com, LLC published a product review titled “Red Yeast Rice Supplements.” Hyman, Phelps & McNamara, P.C. sent an 8-page letter to ConsumerLab on July 17 to…
…this topic.). For more information or to register for the conference, please contact the Center for Business Intelligence toll-free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com. The second…