FDA’s CDER and CDRH Release 2015 Guidance Agenda and Comprehensive Document Search Tool

The Food and Drug Administration seems poised for a busy 2015. The Agency’s Center for Drug Evaluation and Research (CDER) just released their annual guidance document agenda for 2015. They intend to publish 90 guidance documents this year, including several aimed at advertising, biosimilars, pharmaceutical quality and manufacturing standards, and the Drug Supply Chain Security Act. The Center for Devices and Radiological Health (CDRH) released their 2015 plan as well--indicating Laboratory Developed Test and software-related guidances are in the works. To cap off a busy new year, FDA also released a well-organized guidance database and easy-to-use search tool which offers a marked improvement over the previous system. Pharmaceutical Guidance Advertising FDA looks like it will tackle some important issues in upcoming guidance related to advertising, including how companies may promote products using health care economics (a long sought after guidance), social media promotion that includes links to third party sites, direct to consumer TV ads, and more guidance related to unapproved uses of approved medical products. Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs Health Care Economic Information in Promotional Labeling and Advertising for ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs