Items Tagged with 'CDER'

ARTICLES

CDER to Require eCTD Format for Electronic Submissions

Drug manufacturers choosing to submit applications to the 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, an FDA official said.

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FDA to Update Regulation on Combination Products

The intercenter agreements governing how combination and single-entity products are assigned to FDA centers have become “incomplete statements” due to a slew of emerging new products and the large volume of jurisdictional decisions the agency has made in recent years, the FDA said.

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FDA Proposes Requiring Electronic Drug Registration

Fresh off an internal report critical of inaccuracies in the FDA’s drug data system, the agency is proposing a new rule requiring drug manufacturers to electronically register all their products — prescription or OTC — in an Electronic Drug Registration and Listing System (EDRLS).

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