| The most complex combination products are invariably devices involving drugs or biologics, or both. |
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| Insurers and consumers have even more reason to want a break on biologics, which can be vastly more expensive than other drugs. |
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| One reason for creating such products is to deliver drugs or biologics to a well-defined target within the body. |
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| The future of cardiovascular care will be combining devices, drugs, and biologics to take a more intelligent approach. |
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| Then all of a sudden the dot-bomb dropped, and suddenly medical devices and biologics were back in vogue. |
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| Targeted pharmaceuticals and biologics do work for the betterment of healthcare by reducing the cost and time of development and time to market. |
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| It is a powder that is nearly 50 percent mercury and is added to vaccines and other biologics as a preservative. |
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| There is nothing sacred about the sharp lines between drugs, devices, and biologics. |
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| Combining these drugs and biologics with devices offers one avenue for the successful use of such products. |
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| The centers for drugs and biologics both have excellent scientific core competencies in their areas of authority. |
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| Recalls for drugs, biologics, veterinary medicines, and the overwhelming majority of devices are voluntary actions by industry. |
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| In fact, some biologics can offer a break from therapy while the psoriasis remains in control. |
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| While the FDA shares concerns about safety, some insiders argue that scientific advancements have made it easier to characterize and replicate biologics. |
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| However, the law currently doesn't allow for generic biologics. |
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| Hence, drugs or biologics coated onto medical devices have the potential to affect circulation patterns or release of soluble factors from various immune cells. |
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| The process has worked well for some straightforward drug-device combination products, but for more complex products, particularly those involving biologics, it has faltered. |
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| Among other things, it has proposed the creation of a new directorate of biologics and genetics. |
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| When you make a vaccine, there are biologics that are very difficult to make. |
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| Note: CTAs that involve the use of both pharmaceuticals and biologics must be submitted to the appropriate Lead Directorate in duplicate. |
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| Boehringer Ingelheim will further develop its own New Biological Entities' pipeline, but will also aim to remain the partner of choice for our clients for development and manufacturing of biologics. |
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| It has been widely recognized that today therapeutic biologics have become a new but important type of medication. |
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| The FDA is planning to release a draft guidance on follow-on biologics this spring. |
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| At a time when life science innovation is at all-time high, biologics therapies represent a significant part of the pharmaceutical armamentarium and are poised to have a larger role in fighting disease. |
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| Production of high quality biologics, including antibodies and other large macromolecules that require mammalian post-translational modifications. |
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| Bristol-Myers Squibb recently held a groundbreaking ceremony at the site of the company's new biologics manufacturing facility in Devens, Massachusetts. |
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| Biologics Master File will support cGMP grade CRM197 carrier protein use by Reagent Proteins partners in conjugate vaccine clinical development programs. |
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| The Biologics Prescribers Collaborative and the other groups who submitted this joint comment have supported distinct nonproprietary naming for many years. |
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