Skip to main content

Personalized Medicine and Nutrition

BayBiotech.NET
International efforts to complete the human genome project and HapMap (Haplotype mapping of human genome) projects channelized the development of Division of Personalized Nutrition and Medicine (DPNM). Data generated from these projects made us to think in the direction of personalized medicine emphasizing that even though humans are genetically similar, each retains a unique genetic constitution that contributes to the wide array of biochemical, physiological, and morphological phenotypes in human populations. The unique identity is mostly shaped by nutrients and environment in which an individual lives.
DPNM is geared to develop and implement research strategies that account for genetic, environmental, and cultural diversity that influence expression of genetic makeup and produce knowledge for improving personal and public health.
Within DPNM, there are two active divisions—Biometry and Biology. While, Biometry branch works to develop biometrical methods for all aspects of the FDA’s mission, goals, and objectives, the Biology branch is focusing on the broad areas of pharmacogenomics and nutrigenomics—how individuals respond to drugs and nutrients in foods.
To learn more about ongoing research projects evolving the guidelines, follow Personalized Nutrition and Medicine.

Comments

Post a Comment

Popular posts from this blog

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...
Post a Comment
Read more

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!
Post a Comment
Read more

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...
Post a Comment
Read more