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Guidance for Industry - Food and Drug Administration
- https://www.fda.gov/media/86377/download
- review of new drugs2 to address unmet medical need in the treatment of a serious or life- threatening 3 condition: fast track designation, breakthrough therapy designation, accelerated
Expedited Programs for Serious Conditions––Drugs and …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics
- The following four FDA programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment …
Regulatory pathways and approaches to unmet …
- https://www.fda.gov/media/99377/download
- ‘unmet medical needs’ means a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the Community or, even if such a method …
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
- Issued by: Center for Drug Evaluation and Research, Office of New Drugs The Food and Drug Administration (FDA or Agency) is announcing the availability of a …
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
- Specifically, the guidance explains the FDA’s current thinking about possible streamlined development programs and clinical trial designs for antibacterial drugs to …
Unmet medical need - National Institutes of Health
- https://toolkit.ncats.nih.gov/glossary/unmet-medical-need/
- An unmet medical need is a condition or symptom whose treatment or diagnosis is not addressed adequately by available therapy. An unmet medical need includes an …
2018 FDA/NCATS Report on Unmet Medical Device …
- https://www.fda.gov/industry/humanitarian-use-device-hud-designation-program/2018-fdancats-report-unmet-medical-device-needs-patients-rare-diseases
- Summary : The FDA and the NIH National Center for Advancing Translational Sciences (NCATS)/Office of Rare Diseases Research (ORDR) conducted this needs assessment …
Trial Considerations for Unmet Need - Food and …
- https://www.fda.gov/media/99304/download
- Treatment•mechanism(s)If to of resistance in patients be patient needs available before new of antibacterialemergence of drug the development high levels of …
Contents Page i - Food and Drug Administration
- https://www.fda.gov/media/111309/download
- understand unmet medical device needs for rare diseases; generate meaningful data to inform patients, practitioners, policymakers, and device developers on the needs, …
Future unmet medical need as a guiding principle for
- https://pubmed.ncbi.nlm.nih.gov/31233729/
- 'Unmet medical need' is a widely used term in the healthcare sector but a common definition does not exist. The current standard of care determines the current unmet …
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