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…Effects of KSR on brand and generic litigation strategies Panel discussion on acceptable settlement strategies for paragraph IV disputes Litigating paragraph IV disputes with multiple ANDA filers Interpreting forfeiture provisions…
…ourselves on the back and say “atta 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”…
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…
…CBI conference brings together representatives from both the brand name and generic drug industries to discuss litigation strategies, statutory guidelines, current cases and their landmark decisions. A copy of the…
…commonly known as “Hatch-Waxman” or “Waxman-Hatch” depending on when you became familiar with the law. To celebrate, we dredged Hatch-Waxman history to come up with some trivia questions (and also…
…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…
…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…
…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…
…been flagged with only a method-of-use; however, Novartis alleges that the ‘937 patent also includes compound claims that cannot be carved out with a “section viii” statement. Prior to August…
…inflammatory complications associated with COVID-19. Vered Kaplan, CEO of Orgenesis, a global biotech company, which is unlocking the potential of cell and gene therapy including anti-viral technologies relevant for COVID-19…
…action. FDA’s actions are consistent with the Agency’s June 2006 Compliance Policy Guide, in which FDA announced its enforcement priorities for marketed unapproved drugs. These enforcement priorities include taking action…
Hyman, Phelps & McNamara, P.C. and Analysis Group are partnering to host a two-hour timely, informative and free program to discuss current important legal perspectives and analytical trends concerning the…
…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…
…to defend companies against government enforcement actions and advise clients on necessary compliance efforts. The firm’s clients are as diverse as the regulatory issues they face. They range from individuals…
…big firm experience, including litigation experience, and a federal judicial clerkship. E-discovery expertise is a bonus. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please…