China announces plans to fast-track drug approval
Sign Up to like & getrecommendations! Published in 2017 at "Nature"
DOI: 10.1038/nature.2017.22888
Abstract: Policies are expected to speed up access to medicines and boost the country’s pharmaceutical industry. read more here.
Keywords: china announces; fast track; drug approval; plans fast ... See more keywords
Speed and Safety in Drug Approval and Commercialization
Sign Up to like & getrecommendations! Published in 2017 at "Pediatrics"
DOI: 10.1542/peds.2017-0791
Abstract: * Abbreviation: FDA — : Food and Drug Administration I sat across from my patient with recently confirmed relapsed pulmonary osteosarcoma. Having previously endured multiple rounds of chemotherapy, an amputation, and debilitating and, at times,… read more here.
Keywords: hematology; speed safety; drug; safety drug ... See more keywords
Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of managed care & specialty pharmacy"
DOI: 10.18553/jmcp.2017.23.10.1078
Abstract: Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the… read more here.
Keywords: patient centered; centered drug; drug; drug approval ... See more keywords
Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States
Sign Up to like & getrecommendations! Published in 2022 at "International Journal of Environmental Research and Public Health"
DOI: 10.3390/ijerph19052857
Abstract: (1) Background: Drug lag, the delay between the first global regulatory approval and approval by the national health authorities in other countries, impacts the accessibility of drugs. Although the Korean pharmaceutical market has grown significantly,… read more here.
Keywords: approval; drug approval; orphan drugs; drug lag ... See more keywords
Fast Methods for Drug Approval: Research Perspectives for Pandemic Preparedness
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DOI: 10.3390/ijerph20032404
Abstract: Public heath emergencies such as the outbreak of novel infectious diseases represent a major challenge for drug regulatory bodies, practitioners, and scientific communities. In such critical situations drug regulators and public health practitioners base their… read more here.
Keywords: philosophy; pandemic preparedness; methodology; drug approval ... See more keywords