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US FDA has made it mandatory for the manufacturers
of drugs or drug products to submit their
product labels in electronic form from October
31st, 2005. It has put forth a guideline
for the creation and submission of the product
label in electronic format.
The
FDA has confirmed that the SPL standard
will apply only to the content of labeling
provided with original submissions, supplements,
and annul reports for human drug and biological
products.
vACT:SPL™
is a product designed and developed to cater
to electronic submission of patient information
Leaflet(PIL) as per SPL standard encompassing
the following features & benefits.
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