| February 12, 2013 | News for the food and drug law community |
 |  |
| Drugs & Biologics |  |  |
|
- Footnote in court hints at new FDA rules for generic warnings
The FDA may revise regulations so that makers of generic drugs can update labels to warn patients about risks, Ed Silverman writes. The Justice Department filed a friend-of-court brief in a case concerning generic drugs, and it carried this footnote: "This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances." Pharmalot.com/Pharma Blog
(2/11)  
- Early trials may be enough for innovative drugs to win FDA approval
The FDA granted "breakthrough" status to three promising experimental drugs as part of efforts to speed market entry for treatments of life-threatening conditions. "We expect many of these would come available very quickly with Phase 1 data," FDA Center for Drug Evaluation and Research Director Janet Woodcock said. Applications for breakthrough status have been made for 18 other treatments, she said. Bloomberg Businessweek
(2/12)
| Food & Dietary Supplements | | |
|
- Supreme Court to hear case on genetically modified soybeans
A Supreme Court case could determine whether Monsanto and other seed producers can prevent farmers from re-planting genetically altered crops. An Indiana farmer bought progeny soybeans from a grain elevator for planting. A ruling against Monsanto "would devastate innovation in biotechnology," according to the company's brief. The Washington Post
(2/9)
| Medical Devices | | |
|
- Optovue scores 510(k) clearance for OCT system database
Optovue has been cleared by the FDA to incorporate a normative database into the firm's iVue spectral-domain optical coherence tomography device. The iVue SD-OCT technology can use the database to enable the quantitative comparisons of the optic disc and other areas of the eye, as well as tailor OCT scans according to a patient's age, optic disc size and other factors. Healio
(2/8)
| FDLI Items | | |
|
-
2013 conference calendar -- speak, register & save the dates!
There are plenty of speaking opportunities available for this year's FDLI conferences. Please e-mail our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
- Medical Device Compliance, Regulation and Litigation Conference | March 4 | Washington, D.C.
- Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
- Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
- FDLI Annual Conference | April 23-24 | Washington, D.C.
- FDLI International Conference | June 6-7 | Beijing, China. New date!
- Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
- Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Location TBD
- FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
- Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
| SmartQuote | | |
|
 | Do not teach your children never to be angry; teach them how to be angry."
--Lyman Abbott,
American theologian, author and editor
|
| |
| |
|
Read more at SmartBrief.com |
|
A powerful website for SmartBrief readers including:
|
|
|
|
| |
| |
| | Recent FDLI SmartBrief Issues:
- Monday, February 11, 2013
- Friday, February 08, 2013
- Thursday, February 07, 2013
- Wednesday, February 06, 2013
- Tuesday, February 05, 2013
| | | Lead Editor: Tom Parks
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004 | |
| |
|
| © 1999-2013 SmartBrief, Inc.® Legal Information |
|
