Information Hub
Regulatory
FDA Botanical Drug Guidance:
https://www.fda.gov/media/93113/download
IND forms:
IND Forms and Instructions | FDA
Guidance Snapshots:
CDER Manual of Policies and Procedures (MAPPs):
CDER Manual of Policies & Procedures | MAPP | FDA
Drug Master Files (DMFs):
Drug Master Files (DMFs) | FDA
ICH Common Technical Document (CTD):
Mulitdisciplanry Guidance:
Risk, Regulation and Strategy:
researchspace.auckland.ac.nz/bitstream/handle/2292/61072/Lewis-2022-thesis.pdf?sequence=1
ICH Guidelines:
Eudralex Volume 4 EU GMP Guidelines:
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
EDQM Cannabis Flower Monograph:
Botanical Drug Design
Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective:
https://pubs.acs.org/doi/10.1021/acs.jnatprod.9b00949
Natural products in drug discovery: advances and opportunities:
https://www.nature.com/articles/s41573-020-00114-z
Drug discovery from plant sources: An integrated approach:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3456845/
Botanical Drug Development and Quality Standards:
https://pqri.org/wp-content/uploads/2015/10/01-PQRI-Lee-Botanicals-20151.pdf
Plant-derived natural products for drug discovery: current approaches and prospects:
https://link.springer.com/article/10.1007/s13237-022-00405-3
An Overview of Traditional Chinese Herbal Formulae and a Proposal of a New Code System for Expressing the Formula Titles:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC516452/
Herb-Herb Combination for Therapeutic Enhancement and Advancement: Theory, Practice and Future Perspectives:
https://www.mdpi.com/1420-3049/18/5/5125
Integration of high-throughput omics technologies in medicinal plant research: The new era of natural drug discovery:
https://www.frontiersin.org/articles/10.3389/fpls.2023.1073848/full