Drug manufacturers choosing to submit applications to the U.S. Center for Drug Evaluation and Research (CDER) electronically — as opposed to on paper — will have to use a particular electronic format called the electronic common technical document (eCTD) starting Jan. 1, 2008, a U.S. Food and Drug Administration (FDA) official said.
The U.S. Food and Drug Administration (FDA) will update its current good manufacturing practices (cGMPs) quality systems (QSs) guidance to conform to international pharmaceutical QS guidelines, the agency said March 23 at a Drug Information Association conference.
In an effort to ease manufacturers into electronic common technical document (eCTD) formatted submissions, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is accepting electronic submissions that are compliant with the folder structure and naming conventions of the eCTD standard but which lack an extensible markup language (XML) backbone.
A key goal of Good Manufacturing Practice (GMP) training is to bring employees up to a satisfactory level of competence that can be proven to FDA inspectors, according to David Markovitz, president and founder of GMP Training Systems.
The HHS Office of Inspector General (OIG) inspected durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) providers in South Florida in late 2006 and found nearly half were not in compliance with certain Medicare standards.