Last month, FDA announced the publication of a revised version of the Draft Quality Metrics Guidance that it had published back in July of 2015. We had blogged about the original Draft Guidance at that time (see prior posting here). Below we provide a brief …
By Jennifer M. Thomas – Last week, FDA rolled out a new online reporting program, titled “Reporting Allegations of Regulatory Misconduct,” with little fanfare. No blog post in FDA Voice, no press conference, and even the (longwinded) name of the program seems calculated to send the …
By Jennifer M. Thomas – You might have read in our blog post two weeks ago that Quality Egg, LLC executives Austin (Jack) and Peter DeCoster had petitioned for panel rehearing and rehearing en banc of the Eight Circuit opinion affirming their three-month prison sentences. Last …
By Anne K. Walsh & Robert A. Dormer – As we predicted it might, FDA effectively shut down a drug facility based solely on its conduct during an FDA inspection, without any observed GMP or safety concern related to the company’s products or procedures. In a …
By Jennifer M. Thomas – As predicted in our last post on the significant Park-related litigation arising out of the Quality Egg case, Austin (Jack) and Peter Decoster timely petitioned for panel or en banc rehearing of their Eighth Circuit challenge to three-month prison sentences imposed …
By JP Ellison & Wes Siegner – There are 12 pages of FDA forms on the FDA website covering everything from product topics (foods, drugs, cosmetics, etc.) to safety forms and FDA field operations forms. Unless we missed it, one of FDA’s newest forms isn’t on its website. …
By Karla L. Palmer – FDA posted a “Notice” on July 12, 2016, advising compounding pharmacies regulated under Section 503A that, effective August 1, 2016, FDA is changing inspection procedures for Section 503A pharmacies (see Notice here). FDA announced that it now will make a “preliminary assessment” whether compounders …
By Jennifer M. Thomas & John R. Fleder – On July 6, 2016, the Eighth Circuit upheld a district court ruling in United States v. DeCoster that imposed three-month prison sentences and $100,000 fines on Austin “Jack” and Peter Decoster, the owner and chief operating officer, …
By Kurt R. Karst – It’s been a little more than 4.5 years since we first revealed in a December 11, 2011 FDA Law Blog post the fruits of our hunt for the mythical list of pending proceedings under the Drug Efficacy Study Implementation …
By Riëtte van Laack As we reported previously, in 2013, Health Science Funding, LLC (HSF) filed what might be the first medical food lawsuit against FDA. Plaintiff markets a medical food for women with lupus, Prastera® DHEA. Medical foods may be marketed without pre-market approval by …
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. With the international pharmaceutical supply chain imperiled …
By Anne K. Walsh & John R. Fleder – DOJ Deputy Attorney General Sally Q. Yates spoke last week before the New York City Bar Association White Collar Crime Institute to provide an update on the DOJ policy she announced in September 2015, about which we …
The short answer to that question is “No,” says Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro in an article published in the March/April 2016 issue of the Food and Drug Law Institute’s Update Magazine. Mr. Shapiro examines the Department of Justice’s recent criminal prosecution of …
By James C. Shehan – In a bluntly-worded warning letter to contract manufacturer Sri Krishna Pharmaceuticals Ltd. issued April 1, 2016, we see another example of increasing FDA concern over data integrity issues at non-US drug manufacturing facilities, particularly those in India. This rather remarkable letter contains …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the publication of its FDA Deskbook, incorporating more than a century of experience of HP&M’s attorneys from positions in the government and regulated industry. The FDA Deskbook provides a comprehensive resource that details the ins-and-outs …
