Navigation Links
FDA News & Notes - Week of July 25, 2011

SILVER SPRING, Md., July 25, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of July 25, 2011.


FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.

Events and Speeches for the Commissioner and FDA leadership:
Tuesday, 7/26 – FDA Commissioner Margaret Hamburg speaks at the amfAR Capitol Hill Summit held to mark the progress that has been made in the fight against the disease. 1 p.m., Kennedy Caucus Room (R-325), Russell Senate Office Building, Constitution Ave. and Delaware Ave., N.E., Washington, D.C. Space is limited. RSVP to or call 703-288-8696.
Press Office Contact: Raymond Formanek Jr., 301-796-4677,

Meetings, Workshops and Congressional Testimony:
Tuesday, 7/26 – The FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee discusses bioequivalence and quality standards for narrow therapeutic index drug products. 8 a.m., 10903 New Hampshire Ave., Building 31, Room 1503, Silver Spring, Md.
Press Office Contact: Sandy Walsh, 301-796-4669,

Wednesday, 7/27 – The FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee considers strategies for the implementation of quality by design principles within the Office of Pharmaceutical Science review offices. 8 a.m., 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, Md.
Press Office Contact: Sandy Walsh, 301-796-4669,

Wednesday, 7/27 – American Telemedicine Association Policy Summit
Bakul Patel, policy adviser, and Mary Brady, senior policy analyst, from the Center for Devices and Radiological Health speak on mobile health policy and telehealth. 8:30 a.m., The Westin Washington, D.C., 1400 M Street, N.W., Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674,

Thursday, 7/28 – FDA Commissioner Hamburg testifies before the Senate Committee on Health, Education, Labor and Pensions on "FDA User Fees: Advancing Public Health." 9:45 a.m., Dirksen Senate Office Bldg., Constitution Ave. and 1st St., N.E., Room 430, Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674,

Monday, 8/1 –  The first FDA Humanitarian Use Device Workshop provides an opportunity to spend two days developing applications for devices intended to treat or diagnosis a rare disease or condition. 8 a.m., University of Minnesota-Twin Cities Campus, Moos Tower, 515 Delaware Street, S.E., Minneapolis.
Press Office Contact: Sandy Walsh, 301-796-4669,

On the Web:
Tuesday, 7/26 – The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, "Recalls Pending Classification: DRUGS." They will be reposted with their classification once that determination has been made. Send comments or suggestions to
Press Office Contact: Shelly Burgess, 301-796-4651,

Analysis of Premarket Review Times Under the 510(k) Program at Center for Devices and Radiological Health.
Press Office Contact: Karen Riley, 301-796-4674,

Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses
Press Office Contact: Erica Jefferson, 301-796-4988,

FDA Office of Public Affairs Contact Information:
Call or email FDA Office of Public Affairs, 301-796-4540,
List of FDA press officers and beats

More Resources:
FDA News and Events
FDA Photos (Flickr)
Consumer Health Information

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Frost & Sullivan: Western European Markets Confirm Undisputed Convenience and Cost Benefit of Custom Procedure Trays
2. Boston Scientific and Johnson & Johnson Announce Settlement of Patent Disputes
3. Tata Interactive Systems Partners With Bersin & Associates for Exclusive Executive Learning Forum - TLF 2009
4. Sigma-Aldrich (Nasdaq: SIAL) Announces Appointment of George Miller as Sr. Vice President, General Counsel & Secretary
5. Robbins & Myers Announces Regular Quarterly Cash Dividend
6. Delcath Systems, Inc. Appoints Dr. Krishna Kandarpa its Executive Vice President R&D and Chief Medical Officer
7. Frost & Sullivan Lauds Viatronix as European Medical Imaging Emerging Company of the Year
8. Bausch & Lomb Acquires the Commercial Assets of Italian Ophthalmic Pharmaceuticals Company Tubilux
9. Robbins & Myers Announces Fourth Quarter and Full Year 2009 Results
10. Dynatronics Appoints Douglas Sampson as Vice President of Production and Research & Development
11. Frost & Sullivan Identifies Focus on Quality Management and Adoption of a Full-service Model as Keys to the Growth of the European CRO Market
Post Your Comments:
(Date:12/1/2015)... BANGALORE, India and ... (NASDAQ, TASE: MYL) today announced that it expects to ... for developing country markets funded by international donors, TLE400 ... + Efavirenz 400 mg) for $99 per patient, per ... (CHAI) to develop TLE400. The significantly reduced price could ...
(Date:12/1/2015)... , Dec. 1, 2015 Breg, Inc ... services, announced today that it has been awarded three ... Members served by Novation will have access to improved ... bracing products and soft goods dedicated to advancing orthopedic ... The aging U.S. population, rising prevalence of chronic ...
(Date:12/1/2015)... , Dec. 1, 2015 Building ... HIV/AIDS, Johnson & Johnson (NYSE: JNJ ) ... Janssen Pharmaceutical Companies to significantly reduce the burden ... make up 74 percent of new HIV infections ... on World AIDS Day, these new initiatives include ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... SAN FRANCISCO, ... announced that the organization has awarded Education and Developmental Therapies (EDT), an Applied ... The award celebrates exceptional special needs providers that excel in synthesizing the areas ...
(Date:12/1/2015)... ... ... Lutronic, a leading innovator of aesthetic and medical laser and energy-based technology, announced ... the United States. Clarity is a Superior Dual Wavelength Platform which combines two ... platform that is easy to own and operate. , For over a decade, ...
(Date:12/1/2015)... , ... December 01, 2015 , ... XTC Semifinals ... 10 semi-finalists to head to Las Vegas for CES 2016, the world’s largest Consumer ... of Consumer Technology Association Gary Shapiro, Founding Partner of Pacific Investments Veronica Serra, and ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... Nurotron Biotechnology ... in its largest order to date. , The order will be from the ... Nurotron’s Venus Cochlear Implant System is an effective solution for children and adults suffering ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... ... Contact Center Enterprise Authorized Technology Provider (ATP) status from Cisco. This designation recognizes ... and support Cisco Unified Contact Center solutions targeted to the high-end enterprise contact ...
Breaking Medicine News(10 mins):