…drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation (here).  We find it all rather interesting.  After all, data can provide an informative…

…with over 430 sites, and after that, several countries in Europe and in Asia each had over a hundred catalog sites, including Germany, Canada, Italy, France, Japan, the U.K., and…

…federal contract. To state the inverse, the Act does not apply in cases where federal contractors do not use “biotechnology equipment or services” acquired from a “biotechnology company of concern”…

…alleged to be a drug delivery device patent has already led one company to assert in court the patent delisting counterclaim provisions at FDC Act §505(c)(3)(D)(ii)(I) added to the statute…

…the application. Such an understanding is critical to addressing the review division’s findings through additional data or analyses, and is even more essential should the company choose to appeal those…

…defendants allegedly used a national marketing scheme to promote a fraud. If true, they should not get off scot-free if there is a practical statistical way to address the difficult…

…in comments from the National Association of Attorneys General. All of this is the long way to say that Congress’s concern about delays in the issuance of a final rule…

…voluntarily provide timely notice of approval of any ANDA for a generic version of Seroquel or Seroquel XR to AstraZeneca and the Court, even if this case were dismissed without…

…No. 201739 for its “epi-Card” epinephrine product.  Among other things, a court decision could provide an answer to a question posed to FDA several years ago about drug delivery device…

…that an October 2003 warning label other than approved by the FDA would have been in direct actual conflict with Federal law.”  In contradiction, it is plaintiff herein who supports…

…drug as an “antibiotic” (see here). Second, there’s the recent fight over whether the St. Regis Mohawk Indian Tribe can use tribal sovereign immunity to shield patents covering RESTASIS from…

…a not-for-profit, global organization dedicated to bringing health care product development professionals together in a neutral environment to improve health and well-being throughout the world.  The conference focuses on the…

…practical real-world examples that will help you to excel in your everyday practices. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks!…

…that transmittal occurs after normal business hours.  In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that would mean the 60-day period would have begun on…

…approval).  In April 2007, the U.S. Patent and Trademark Office (“PTO”) denied the PTE request.  Among other things, the PTO cited Unimed, Inc. v. Quigg, 888 F2d 826; 12 USPQ2d…