A representative from the FDA was also invited. For preparation, each expert was provided with an agenda and compiled information on the COAs to review prior to the meeting. Phase 2—meeting The workshop meeting was attended by 29 invited experts, the majority from the USA (n = 25)....
Overactive bladder (OAB) presents a high prevalence of 16–18% worldwide. The pathophysiology of OAB is still poorly understood while effective therapy or countermeasure are very limited. On the other hand, medicinal plants and herbal remedies have been
The quality evaluation of MedDRA-ICD mapping was focused on the PT level. PT terms are preferred for the majority of adverse event reporting systems. Take FAERS from FDA for example, all the adverse reaction were recorded on the PT level. In OMOP CDM, we only found around 200 mapped pairs...
With the rise of new diagnostic and data-driven approaches that deepen our understanding of the molecular basis of disease, this centuries-old dream has come closer to reality. Nowadays, the awareness of the potential of PHC is also emerging in the patient community and its meaning goes far ...
Although common sense indicates that a food additive is something added to food, the term food additive has a specific legal meaning: a substance whose intended use “results or may reasonably be expected to result, directly or indirectly, in its becoming a component of any food or otherwise ...
Although the goal of translational research is to bring biomedical knowledge from the laboratory to clinical trial and therapeutic products for improving health, this goal has not been well achieved as often as desired because of many barriers documented
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,”“expect,”“plan,”“target” and similar expressions (as well as other words or expressions referencing future events, condit...
Both tissue-of-origin studies and tumor-agnostic/genomic-based studies are drug-centered, meaning that the trial offers the same drug(s) to each patient and the patient must fit the trial. Patients are chosen for the trial based on their commonalities, that is, whether they have the same ...
which is currently under review by FDA, an additional indication in chronic kidney disease, for which we plan to file with the FDA next month , and the development of an auto-injector that would complement the current on-body infusor, ...
QUH- OTC hearing aid that may be sold online AND in stores, pharmacies, etc. QDD was created in 2018 when the FDA grantedde novo(new product category) status to the first Bose self-fitting hearing aid—a device that would never actually be sold commercially but was still subject to labe...