Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Beginning on May 23, 2018, the Center for Veterinary Medicine (CVM) will host a three-part webinar series to provide information on the new animal drug application approval process. CVM’s Office of New Animal Drug Evaluation (ONADE) is hosting this webinar series to address the FDA Electronic Submission Gateway (ESG) and CVM Electronic Submission System (ESS) registration processes as well as to provide information on how to use the eSubmitter tool.
Since the release of eSubmitter in March 2011, the number of electronic submissions has increased. The purpose of these webinars is to support the use of eSubmitter in the new animal drug application approval process as we move to 100% electronic submission on October 1, 2018, with the anticipated reauthorization of the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). Each webinar listed below will be live-cast and recordings will be available on FDA.gov shortly after the presentation date. Read entire article.