• where experts go to learn about FDA
    • The Brand-Name Side of the Exclusivity Equation; Exclusivity Under FireSeptember 10th, 2012

      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 …

    • If You are A Mobile App Developer, Get it Right from the Start, Please!September 9th, 2012

      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 …

    • KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17PSeptember 6th, 2012

      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 …

    • Hold the Fructose: FDA Petitioned to Act Against Certain High Fructose Corn SyrupsSeptember 5th, 2012

       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 …

    • The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition StrategiesSeptember 4th, 2012

      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 …

    • The Obesity Epidemic: FDA’s Growing Waistline!September 3rd, 2012

      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 …