Earlier this year, we blogged about FDA’s Field Alert Report (or FARs) reporting requirements under 505(k) of the Federal Food, Drug, and Cosmetic Act. The requirements have been in effect since 1985, when the agency promulgated the regulatory provision at 21 CFR 314.81(b)(i). At the time …
Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see here and here) amends the Pharmaceutical Annex to the 1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and …
FDA’s Field Alert Report (or FARs) reporting requirements are authorized under 505(k) of the Federal Food, Drug, and Cosmetic Act. The requirements have been in effect since the agency promulgated the regulatory provision at 21 CFR 314.81(b)(i) in 1985. The regulatory provision states, in part, …
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 We had blogged about the original Draft Guidance at that time (see prior posting here).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 John R. Fleder & Mark I. Schwartz – We all know that under the so-called “Park Doctrine”, corporate executives can be criminally prosecuted under the FDC Act for violations of that Act even absent any showing that the executives acted with any wrongful intent. A prosecution …
