- NLM Digital Collections - Drugs against cancer : stories of discovery and the quest for a curePublication: Bethesda, Maryland : National Cancer Institute, [2022]... the Quest for a Cure From discovery to clinical application by Kurt W. Kohn, MD, PhD Developmental Therapeutics ... progressed to the current era of research and clinical application. Chapters 1 through13 relate the history of discovery ...
- NLM Digital Collections - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:...Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 8, 2023... villi to secrete and absorb CSF). The specific clinical application and the materials used in the manufacture of ... observed by investigators during the course of a clinical study with observations ... PMAs, HDE applications, and De Novo requests) In addition to the ...
- NLM Digital Collections - Use of International Standard ISO 10993-1 : "Biological evaluation of medical devices - part ....Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020... villi to secrete and absorb CSF). The specific clinical application and the materials used in the manufacture of ...
- NLM Digital Collections - COVID-19 : DOD has focused on strategy and oversight to protect military servicemember health ...Publication: Washington, DC : United States Government Accountability Office, June 2021... An advantage of this vaccine is its potential application as a universal vaccine for future coronaviruses. This vaccine uses nanoparticles of an iron-containing protein called ferritin. Researchers ...
- NLM Digital Collections - S12 nonclinical biodistribution considerations for gene therapy products : guidance for ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023... the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in ...
- NLM Digital Collections - Q3D(R2) elemental impuritiesPublication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022... the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in ...
- NLM Digital Collections - Drug products, including biological products, that contain nanomaterialsPublication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022... trapped, bound, encapsulated, or associated with a nanomaterial. Nanoparticle: A particle with all three dimensions in the nanoscale range. Nanoscale: Typically within the size range of approximately 1 to 100 nm. Premarket application: Refers to Investigational New Drug (INDs) applications, New ...
- NLM Digital Collections - S5(R3) detection of reproductive and developmental toxicity for human pharmaceuticalsPublication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021... the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in ...
- NLM Digital Collections - Q5A(R2) : viral safety evaluation of biotechnology products derived from cell lines of human ....Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2024... the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in ...
- NLM Digital Collections - Enforcement policy for face masks, barrier face coverings, face shields, surgical masks, and ....Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, September 2021... product does not include any drugs, biologics, or nanoparticles; · The ... in a clinical setting where the infection risk level through inhalation ...
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