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In response to the many pharmaceutical, biotech, device and diagnostic companies seeking assistance with the new Food and Drug Administration (FDA) laws, the REMS Group LLC today announced its formation.
"We meet with our clients to review their product attributes, design a REMS program that will meet the FDA's high standards, and implement the REMS initiatives," said Nicole Stouffer, president of the REMS Group. "Our continual focus on enterprise and sales rep training and vital communications helps to ensure timely, successful product launches and continued marketing efforts."
During the drug application process, the FDA requires a REMS plan to ensure that the benefits of a drug outweigh the risks of the drug. In addition, the FDA may require the submission of a REMS for an already-approved drug if the FDA becomes aware of new safety information.
The FDA has since required REMS of various drugs in the new drug application process as well as in the post-approval environment. Notably, the FDA recently announced the first class-wide REMS requirements for opioid drugs.