With an optimized delta certification for product approval, this secure service platform can be tailored to fit the needs of each individual NFC deployment.
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The date of initial product approval will also be placed on the label, so doctors and patients can judge how much experience prescribers have with the drugs.
Although not harping on the role of the FDA, it is clear from the analysis that pretty much the entire collapse was due to delayed product approval.
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Globalize the total value chain (product planning, product development, approval, procurement, production, and sales).
Its purpose is to incubate single-product firms and sell them to a larger medical-device company to get the product through FDA approval.
In the US., Elizabeth Warren who largely created the Consumer Financial Protection Bureau, has suggested any new product require regulatory approval before they are launched.
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Brand-name drugmakers, though, can update warnings and precautions on product labeling before obtaining FDA approval.
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It reminds me of a biotech stock with everything hinging on FDA approval of its single product.
Roche is expected to receive approval for a rival product, Pegasys, this month.
Start-ups have to gain the trust of doctors who prescribe these items and depending on the product, secure Federal Drug Administration approval.
For most other claims, such as reducing cellulite, firms need no government approval before marketing a product, although they are supposed to have data on hand to support their claim.
But the Precidian product, which still needs SEC approval, would execute such orders through a blind trust and leave it up to each manager how often to fulfill the disclosure requirement.
Whether a eyelash product's enhancement claims would require approval, would be determined on a case-by-case basis, she adds.
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This showed that GSK had an honest belief that these preliminary data on safety were reassuring as the company was considering whether to submit new (more positive) safety wording for inclusion in the product's label to regulators for approval.
For eight years Isis survived without a substantial product, and in 1998 it won federal approval of Vitravene, an eye infection drug for AIDS patients.
We know this may not be the most exciting first product to get the all-important seal of approval, but you've got to start somewhere.
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The current re-structuring of this approval process, due to the Government Protective Marking Scheme review and the new CESG Commercial Product Assurance scheme has an impact on the timeline for BlackBerry 10 to receive a similar level of approval.
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In general, an eyelash-growth claim "would indicate an intent to affect the structure or function of the body, and thus, cause the product to be a drug, " which would require FDA approval, says Shelly Burgess, a spokeswoman.
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The next day ImClone announced that the U.S. Food and Drug Administration had rejected its application for the approval of its Erbitux cancer drug, the one product in its pipeline, causing a steep decline in the share price.
In December Celgene won approval for its second drug, Revlimid, the product of a 13-year quest to develop a version of thalidomide that would be as potent against cancer but would lack most of the old drug's side effects, such as nerve damage and fatigue.
Pre-approval was automatic because regardless of the borrower profile presented, a mortgage product could be found.
These are the top-tier Islamic scholars whose stamp of approval is required before the world's banks can market a new financial product as being consistent with Islamic law.
One month after the merger announcement, Robison, Executive Vice President Clarke and a few other execs entered a "clean room, " where 10, 000 decisions about the new company, from what product lines to keep to which pension plan to use, would be made ahead of the merger's approval.
Mortgage pre-approval was relegated to a low priority function and the quality of the vetting process and the resulting finished product suffered.
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