Advarra
MARCH 31, 2023
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials. Why Does the IBC Need to do a Risk Assessment?
Pharmaceutical Technology
SEPTEMBER 5, 2022
Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.
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Pharmaceutical Technology
SEPTEMBER 7, 2022
The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. Pharmaceutical companies are increasingly integrating data-driven and software-centric medical adherence products to improve patient compliance. Patient adherence.
Advarra
OCTOBER 26, 2023
Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.
WCG Clinical
NOVEMBER 17, 2023
Although the NIH Guidelines were originally written with non-clinical laboratory research in mind, they also apply to human gene transfer (HGT) research, wherein rsNA or rsNA-containing products are administered to research participants. Since then, however, certain genetic engineering technologies (e.g.,
FDA Law Blog
FEBRUARY 7, 2023
It is common to refer to FDA regulations as either pre-market, meaning they are applied before the device may be marketed, or post-market, meaning that compliance is generally required only after the device is brought to market, with some exceptions.
FDA Law Blog
FEBRUARY 9, 2024
is used in a clinical investigation of a drug or biologic under IND and the DHT meets the definition of a significant risk device a submission of an IDE to the FDA is required unless all the information required for the IDE is contained in the IND. smartphones and tablets) for remote data acquisition in a clinical investigation.
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