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Methodology of drug trials in migraine: History and suggestions for the future.
Cephalalgia
December 2024
Danish Headache Center, Department of Neurology and Translational Research Center, Glostrup, Denmark.
There is a multitude of scientific papers and guideline papers on the methodology of drug trials in migraine. Here, we try to condense this into a single paper and to make proposals for future consideration. Literature known by the authors and from reference lists of relevant publications was used for the history.
View Article and Find Full Text PDFHollaender award 2023: Adventures in applied genetic toxicology.
Environ Mol Mutagen
November 2024
Independent Scientist, Annapolis, Maryland, USA.
This work describes career "adventures" into applied research in environmental mutagenesis. Surprising and interesting results, as well as publications in Nature and Science, may counter an assumption that applied research is not as exciting or impactful as basic research. The narrative is described in terms of "mentors," whose advice had a lasting impact and resonated in many ways.
View Article and Find Full Text PDFFrom bacterial operons to gene therapy: 50 years of the journal Cell.
Cell
November 2024
Department of Biochemistry and Molecular Biophysics, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA; Zuckerman Institute of Mind Brain and Behavior, Columbia University, New York, NY, USA; New York Genome Center, New York, NY, USA. Electronic address:
Recombinant DNA technology has profoundly advanced virtually every aspect of biological and medical sciences, from basic research to biotechnology. Here, I discuss conceptual connections linking fundamental discoveries that were enabled by the technology, advances in the understanding of gene regulation in both prokaryotes and eukaryotes, and the recent FDA-approved CRISPR-based gene therapy for sickle cell anemia and β-thalassemia based on transcriptional derepression.
View Article and Find Full Text PDFExpediting treatments in the 21st century: orphan drugs and accelerated approvals.
Orphanet J Rare Dis
November 2024
EveryLife Foundation for Rare Diseases, Washington, DC, USA.
Background: In response to activated patient communities' catalyzation, two significant efforts by the FDA to expedite treatments have now been in place for multiple decades. In 1983, the United States Congress passed the Orphan Drug Act to provide financial incentives for development of drugs for rare diseases. In 1992, partly in response to the HIV epidemic, the FDA implemented Accelerated Approval (AA) to expedite access to promising new therapies to treat serious conditions with unmet medical need based on surrogate marker efficacy while additional clinical data is confirmed.
View Article and Find Full Text PDFDSHEA 1994 - Celebrating 30 Years of Dietary Supplement Regulation in the United States.
J Diet Suppl
December 2024
Department of Environmental Health Sciences, Fay W. Boozman College of Public Health, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the FDA's statutory authority to regulate dietary supplement products as a category of food in the United States. As we celebrate 30 years post-DSHEA, it is important to reflect on its significance for public health, influence on the continuously evolving and expanding product category, the current regulatory framework, and potential opportunities or modernizing oversight to ensure a strong and well-regulated marketplace. An estimated three-fourths of U.
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