Skip to main content

Nanotechnology Interest Group

BayBiotech.NET
As per definition of National Technology Initiative, nanotechnology is the understanding and control of matter at dimensions between approximately 1 and 100 nanometers. Encompassing nanoscale science, engineering, and technology, nanotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale. According to NTIG at this scale unusual physical, chemical, and biological properties can emerge in materials and the properties may differ in important ways from the properties of bulk materials and single atoms or molecules.
Recognizing a great potential for this technology for drug delivery/ device in medicine, in July 2007 FDA issued a press release outlining the regulatory challenges that the implementation of the technology will have for the agency and geared up towards developing guidance as well as regulations to address the benefits and risks of drugs and devices using nanotechnology. As it is obvious, development and Implementation of nanotechnology in medical field will require multiple expertise (device, drug, engineering and more) agency has formed a nanotechnology interest group (NTIG) to facilitate the regulation of nanotechnology products. NTIG is made up of representatives from multiple centers (so far FDA and 22 other federal agencies are members) and meets quarterly to ensure there is effective communication between the Centers. Most of the Centers also have working groups that establish the network between their different components. To find out more about the national Nanotechnology Initiative visit http://www.nano.gov/.
For more information on the agencies outlook on Nanotechnology products if you have an interest in developing a drug or device at nanoscale visit the link: http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm

Comments

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...

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!

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...