By Kurt R. Karst – In the world of Hatch-Waxman, disputes over 180-day generic drug exclusivity have been commonplace for well over a decade now. Indeed, in 2012 alone there have already been a few lawsuits filed against FDA concerning generic ACTOS and generic PROVIGIL …
By Carmelina G. Allis – If you are a mobile app developer, be sure to review the FTC’s newly published guidelines on truth-in-advertising and privacy principles, “Marketing Your Mobile App, Get it Right from the Start.” They apply to you, whether you are a start-up …
By Kurt R. Karst – In a decision handed down late in the day on Thursday, September 6th, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia dealt a blow to K-V Pharmaceutical Company’s (“KV’s”) efforts to “restore” orphan drug …
By Ricardo Carvajal – A consumer group, Citizens for Health, submitted a citizen petition (Docket No. FDA-2012-P-0904) to FDA asking the agency to “take action to protect the public from the illegal, mislabeled use of high fructose corn syrup (‘HFCS’) that is above 55 percent fructose” and …
By Kurt R. Karst – As we patiently await FDA’s next annual report to Congress on 505(q) citizen petitions (see our previous posts on FDA’s annual reports here, here, and here) we thought we would take a minute to share with our readers some observations …
By Kurt R. Karst – One recent afternoon we returned to our office from a meeting to find the new (2012) nine-volume set of Title 21 of the Code of Federal Regulations (“CFR”) placed on our desk chair. There’s a special place on our desk …
