Sections
Neighborhoods
Features
Follow Us
NHI Newsletter
Legal Notices
Some Favorite Sites
- 5 Snacks After 10
- Abram Katz
- African independent
- At Risk for HD
- Back To Basics
- barista
- Branford Eagle
- Business NH
- Conn Art Scene
- Cornwall-On-Hudson
- Crosscut
- CT Business Litig
- CT Capitol Report
- CT Energy Blog
- CT Enviro Headlines
- CT Green Scene
- CT Law Tribune
- CT Local Politics
- CT Mirror
- CT News Junkie
- CT Watchdog
- CTV
- Design New Haven
- Gotham Gazette
- Hartford Guardian
- Josiah Brown
- Karman Turn
- La Voz Hispana
- Laurel Club
- Len's Lens
- Magrisso Forte
- Media Attache
- Media Nation
- Medical Intelligence
- Middletown Eye
- MinnPost
- My Left Nutmeg
- NBC Connecticut
- NH Advocate
- NH Register
- NH Review of Books
- NH Youth Map
- Northampton Media
- OneWorld
- Only In Bridgeport
- Oral History Project
- Reddit NH
- Road To Greenness
- Saved By Design
- See Click Fix
- Smartpill Design
- Specials In NH
- St. Louis Beacon
- Taste Of NH
- Tom Ficklin
- Valley Independent Sentinel
- Voice of SD
- VT Digger
- WFSB-TV
- WPKN Today
- WTNH
- Yale Daily News
- YourCT
Government/ Community Links
- Advocate Calendar
- Agency on Aging
- Animal Shelter Volunteers
- Arte Inc.
- Arts Council
- Beth El Keser Israel
- Bike New Haven
- Chamber of Commerce
- Children's Museum
- City of New Haven
- CitySeed
- Citywide Youth
- Community Loan Fund
- Community Mediation
- ConnCAN
- Creative Arts Workshop
- CT BAEO
- CT Tech Council
- Dariba Referrals
- Data Haven
- Elm City Cycling
- Elmseed
- Empower NH
- Friends Of Wooster Sq.
- GAVA
- Habitat For Humanity
- Info New Haven
- IRIS
- Jazz Haven
- Jewish Federation
- Job Finder
- Junta
- Labor History
- LEAP
- Legal Aid Network
- Literacy Coalition
- Magrisso Forte
- Mary Wade
- Music Haven
- New Haven 828
- New Haven Chorale
- New Haven Reads
- New Life Corp.
- NH Bulletin
- NH Land Trust
- NH Symphony
- NH/Leon Sister City
- NHS
- Orchestra NE
- PAR
- Parents Available to Help
- Pat Dillon
- Peace News
- PechaKucha
- Planned Parenthood
- Police
- Promoting Enduring Peace
- Public Allies CT
- Public Library
- Public Schools
- Public Works
- Rainbow Girls
- Register Calendar
- REX
- ROOF
- SAMA
- SCSU Events
- Share Our Voices
- Shubert
- Solar Youth
- Soul-O-Ettes
- Squash Haven
- United Way
- Urban Design League
- Urban Resources Initiative
- Ward 25 Blog
- Ward 26 Blog
- Westville Chabad
- Westville Renaissance
- Westville Synagogue
- Workforce Alliance
- Yale Events
- Yeshiva NH Shul
- Yeshiva Of NH
- Youth Continuum
FDA Process For Nano Drug Review “Adequate,” Official Says
by Gwyneth K. Shaw | Oct 18, 2010 3:48 pm
Commenting has been closed | E-mail the Author
Posted to: Nanotech
(NHI Nanoblog) POTOMAC, Md.—The U.S. Food and Drug Administration is still evaluating whether its policies need tweaking to deal with the increasing development of drugs that use nanomaterials, but the agency’s current procedures are “adequate” for the time being, an official told a conference here.
Nakissa Sadrieh, associate director of research and policy implementation in the FDA’s Office of Pharmaceutical Science, said that the agency’s existing guidelines for submitting new products for approval should cover most questions for applicants.
“There’s no need right now ... to issue guidance documents specifically for nanomaterials,” Sadrieh said. “The existing framework can accommodate the kind of nanoparticle therapeutics under development.”
Sadrieh spoke at a conference jointly hosted by the the American Society for Nanomedicine and National Institutes of Health’s Office of Aids Research and the Division of AIDS at the NIH’s National Institute of Allergy and Infectious Diseases. The main theme involved growing efforts to put nanotechnology to use in preventing and treating HIV, and eventually developing a vaccine for the infection.
Pressed by some in the audience about anxiety among drug developers—particularly academics—who want more specifics from the FDA, Sadrieh said additional guidelines are probably unnecessary. That’s because the agency regards the process of considering nanomaterials derived from drugs and other substances that have already been approved as fairly similar to the current procedures. She added that specificity will come in individual interactions between applicants and the agency.
“We’re viewing nanoparticle-containing drugs as just new drugs,” Sadrieh said.
Because super-small nanomaterials are part of such a broad category, it’s difficult to generalize and create one-size-fits-all guidelines, she said.
The FDA is in the process of putting together a database of both approved drugs and materials that are under review. Sadrieh stressed that the burden is on applicants to understand their material deeply, in order to provide the best information for the FDA when seeking approval for new things. That means being able to specify all of the materials involved, their stability, and how to achieve a consistent method of quality control.
Tags: FDA, nanotech
Post a Comment
Comments
There were no comments
