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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.
The FDA is calling on the pharmaceutical industry to help its regulatory project managers gain a greater understanding of the drug manufacturing process as part of its ongoing effort to bridge the information gap between industry and the agency. Read More
The FDA is calling on the pharmaceutical industry to help its regulatory project managers gain a greater understanding of the drug manufacturing process as part of its ongoing effort to bridge the information gap between industry and the agency. Read More
The FDA is looking into ultimately moving to an all-electronic submission system for regulatory information in all its divisions and will hold a public hearing on the proposal next month.
The FDA will hold a Dec. 11 public meeting to discuss its proposed electronic identification system for drugs and other changes to the National Drug Code (NDC) Directory. The agency also extended the period to make comments on the proposals to Jan. 26, 2007.
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.
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).
CDER has announced that its Advisory Committee for Pharmaceutical Science will hold a public meeting Oct. 5 and 6 in the agency’s building at 5630 Fishers Lane, Rockville, Md.
The FDA’s Center for Drug Evaluation and Research recommends in a new guidance that developers of antiviral drugs and biological products conduct nonclinical studies on a range of subjects before starting a Phase I clinical trial.