Drugs
The Federal Trade Commission (FTC) has issued an enforcement policy statement about advertising and promotional messages integrated into and presented as non-commercial content, often referred to as “native advertising”. The statement summarizes the principles underlying the commission’s enforcement actions, advisory opinions, and other guidance over many decades addressing
FDA Policy/General
Federal Register Final rule: FDA is amending the biologics regulations by removing the Hepatitis C Virus (HCV) “lookback” requirements for review of historical testing records. These regulations expired on 8/24/15 due to the sunset provision provided under the regulation. To view this final rule, click here.
FDA Policy/General
Federal Register Notice: FDA has determined that Kytril (granisetron hydrochloride) tablets, equivalent 1 mg and 2 mg base, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for Kytril if all other legal and regulatory requirements are met. To view
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Genentech’s Kadcyla (ado-trastuzumab emtansine) for extending a patent which claims the human biological product. Kadcyla is indicated as a single agent, for treating patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane,
FDA Policy/General
Federal Register Notice: FDA is announcing the opportunity for externally-led patient-focused drug development meetings. FDA recognizes that there are many more disease areas than can be addressed in the planned FDA meetings under PDUFA V and it welcomes patient organizations to identify and organize patient-focused collaborations to
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