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Unmet Medical Need: An Introduction to Definitions and …
- https://pubmed.ncbi.nlm.nih.gov/31708064/
- Background: Despite increasing informal and formal use of unmet medical need (UMN) in drug development, regulation, and assessment, there is no insight into its definitions in …
Antibacterial Therapies for Patients With an Unmet …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/antibacterial-therapies-patients-unmet-medical-need-treatment-serious-bacterial-diseases
- Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases GUIDANCE DOCUMENT Antibacterial …
Antibacterial Therapies for Patients With an Unmet …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/antibacterial-therapies-patients-unmet-medical-need-treatment-serious-bacterial-diseases-questions
- Center for Drug Evaluation and Research, Office of New Drugs The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft …
Accelerated Approval Program | FDA
- https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
- A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical …
What constitutes an "unmet medical need" in oncology?
- https://pubmed.ncbi.nlm.nih.gov/28395768/
- In conclusion, "unmet medical need" has been used to describe cancer indications that are rare, and have few options and poor survival outcomes. However, the term has also been …
Accelerated Approval | FDA - U.S. Food and Drug …
- https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval
- Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations. These …
Antibacterial Therapies for Patients With an Unmet …
- https://www.federalregister.gov/documents/2022/05/24/2022-11117/antibacterial-therapies-for-patients-with-an-unmet-medical-need-for-the-treatment-of-serious
- FDA is announcing the availability of a draft guidance for industry entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of …
Antibacterial Therapies for Patients With an Unmet …
- https://www.fda.gov/media/158589/download
- 21 diseases in patients with an unmet medical need, including patients with a serious bacterial 22 disease for which effective antibacterial drugs are limited or lacking.3 …
Triple-negative breast cancer: an unmet medical need
- https://pubmed.ncbi.nlm.nih.gov/21278435/
- Triple-negative breast cancer, characterized by tumors that do not express estrogen receptor (ER), progesterone receptor (PR), or HER-2 genes, represents an important …
Is there an unmet medical need for improved hearing …
- https://pubmed.ncbi.nlm.nih.gov/35833443/
- 1 Institute for Auditory Neuroscience and InnerEarLab, University Medical Center Göttingen, Göttingen, Germany. 2 Auditory Neuroscience and Optogenetics Laboratory, German …
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