Year: 2013

It’s that time of year again when we at the FDA Law Blog ask our loyal readers to nominate us for the American Bar Association’s (“ABA’s”) Blawg 100.  It’s a list of the top 100 legal blogs – or “blawgs” – in the blogosphere.  With …

By Jennifer D. Newberger – At long last, 16 years after the most recent version, FDA has issued a new draft guidance about medical device reporting for manufacturers.  Companies have long complained about the ambiguities in the regulation.  In a typical case of “be careful what …

By Kurt R. Karst –       You know the drill . . . .  One organization comes out with a report saying one thing supported by various data.  Days later, another organization comes out with a report saying another thing supported by other data.   In what …

Two companies, DKSH Italia Srl and Polycell Technologies LLC, have filed a citizen petition with FDA asking that it expand the health claim on soluble fiber and coronary heart disease to include their product, Glucagel.  The petition describes Glucagel as a “barley beta-glucan fiber that …

By Kurt R. Karst – Although the battle over the appropriate test to apply to drug patent settlement agreements (aka “reverse payment” or “pay-for-delay” settlement agreements) when evaluating whether or not they are immume from antitrust attack ended with the U.S. Supreme Court’s June 17th decision …

By Kurt R. Karst –       Back in July 2010 we took a look at the historical growth of so-called “Patent Use Codes” (“PUCs”), those numbers and narratives listed in an Orange Book Addendum corresponding to a listed method-of-use patent.  This was long before the U.S. …

By Kurt R. Karst –       As you might imagine, we’re pretty avid FDA docket watchers.  As followers of this blog know, we track FDA petition decisions and regularly update our popular FDA Citizen Petition Tracker.  Keeping close tabs on FDA decisions and announcements posted on …

By Kurt R. Karst –       When the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-0142) on June 24th, ruling that state-law design-defect claims that turn on the adequacy of a drug’s warnings are preempted by the FDC …

By Kurt R. Karst –       It’s a quiet news week here in the U.S. with the Independence Day holiday approaching.  But the news void has given us an opportunity to catch up on a few items we put on a backburner and intended to tackle …

By Alexander J. Varond – On June 25, FDA released a draft guidance entitled “Expedited Programs for Serious Conditions—Drugs and Biologics” and a related Manual of Policies and Procedures entitled “Review Designation Policy: Priority (P) and Standard (S).”   The draft guidance provides important insight into FDA’s …

By Ricardo Carvajal – A federal district court rejected FDA’s proposed “target timeframes” for issuance of regulations to implement major provisions of the Food Safety Modernization Act ("FSMA"), finding them to be “an inadequate response to the request that the parties submit a proposal regarding …

By Dave B. Clissold – Earlier this week, FDA’s Center for Tobacco Products ("CTP") released its first determinations regarding the marketing of new tobacco products through the substantial equivalence (SE) pathway.  CTP authorized the marketing of two new tobacco products and denied the marketing of …

By Jamie K. Wolszon & Alan M. Kirshenbaum ¬− On June 3, 2013, the U.S. District Court for the Southern District of New York ruled that a drug company co-pay subsidy program did not violate the Racketeer Influenced and Corrupt Organizations Act (RICO) under theories of …

By Kurt R. Karst –  It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …

By John R. Fleder – The Children’s Online Privacy Protection Act (“COPPA”) will celebrate its super, sweet 16 next year.  The FTC handles most COPPA enforcement and will no doubt mark the occasion with not-so-super or sweet enforcement.  The FTC has issued an amended COPPA rule, …