PharmTech

SPL Now "Only Acceptable" Format for CBER Original Submissions

According to a July 11, 2008 memorandum posted by the Center for Biologics Evaluation and Research, starting Oct. 15, Health Level 7 structured product labeling in XML (extensible markup language) ...
Royal Society of Chemistry

Structured Product Labeling (SPL) Preparing for FDA Electronic Drug Registration and Drug Listing

The FDA Amendments Act placed into law the requirement for electronic drug establishment registration and drug listing. FDA is adopting the use of extensible markup language (XML) files in a standard ...
Computerwoche Online

FDA to drug makers: Submit labels electronically

The change, which went into effect last week, will keep the public better informed and improve patient safety, according to a statement from the FDA. The new regulation will allow health care ...
Medscape

Introduction to the New Prescription Drug Labeling by the Food and Drug Administration

Developing standards for the conversion of paper labeling to an electronic format is a high priority for FDA. The content and format revisions to the prescribing ...
PharmTech

FDA Issues Structured Product Labeling Guidance; Says Delays Will Not Occur

The US Food and Drug Administration issued a new guidance Monday on indexing structured product labeling. The Center for Biologics Evaluation and Research and the Center for Drug Evaluation and ...