FDA Policy/General
Federal Register Notice: FDA is correcting a notification of a public hearing entitled “Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments” that appeared in the 10/30/15 Federal Register. It published with conflicting information about who
FDA Policy/General
Federal Register Proposed order: FDA is issuing a proposed administrative order to reclassify the electroconvulsive therapy (ECT) device for use in treating severe major depressive episodes associated with major depressive disorder or bipolar disorder in patients 18 years of age and older who are treatment-resistant or who require a
Drugs
A 9/8-9/19/14 FDA inspection at the Sun Pharmaceuticals drug manufacturing facility in Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/17/15 Warning Letter. Specific violations identified by the investigators included: failing to establish and
FDA Policy/General
Federal Register Notice: FDA’s Risk Communication Advisory Committee will meet 2/16 from 9 a.m. to 5 p.m. and February 17, 2016, from 9 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room