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Rules change for FDA medical device panels

The U.S. Food and Drug Administration has announced that it is changing the way its expert panels handle public hearings on medical devices under review for premarket approval.
The changes are being made because of the increasing number of panel meetings. Read about the rule changes at:
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209791.htm

Girls Just Want to Have Fun – in Memphis

Cyndi Lauper came to Memphis several weeks ago to record her new album, “Memphis Blues.” Here’s some video she shot of herself Downtown. (Warning: she’s a little, ah, unsteady with the camera.)

Vasco Smith Honored With Building Renaming

The Shelby County administration building is now the Vasco A. Smith Jr. Administration Building.

The building was formally rededicated Monday morning at a ceremony honoring the longtime Shelby County commissioner and civil rights activist who died last year.

The ceremony was a gathering of fellow veterans of the civil rights era in Memphis as well as figures from the past and present of Shelby County politics.

Former County Commissioner Cleo Kirk remembered Smith, his political mentor, as “a fearless man.”

“If you wanted a good fight, threaten him,” Kirk said. “He found the injustice in things and he attacked it.”

Retired Judge Russell Sugarmon, along with Smith and others, formed the foundation of the city’s civil rights establishment in the 1950s, said Smith’s fight to form The Regional Medical Center “made the potential for a greater medical center possible.”

Former County Commissioner Charles Perkins, who worked with Smith on the creation of The MED, said it “raised the level of medical care all over.”

Smith was remembered a week after the memorial service for another civil rights icon, the Rev. Benjamin Hooks. Sugarmon said the Memphis movement “produced more leadership … than any other city in the South.”

Smith’s widow, former school board member and long time local NAACP executive secretary Maxine Smith, remembered her husband as a tough advocate who was plain spoken and blunt in his dealings with opponents.

“Maybe we did a little good when we stepped out at Memphis State,” she said referring to her attempt, with others, to enroll in and integrate what was then Memphis State University in the 1950s. She was denied admission. Smith will be presented with an honorary doctorate from what is now the University of Memphis in graduation ceremonies this spring.

“I’ve had a good life,” she said. “I’ve had a real good life thanks to Vasco.”

FDA official plans meeting on 510(k) rules

There’s an interesting article in Friday’s online edition of the StarTribune about how the medical device industry in Minnesota is being very proactive as the FDA considers changes to the 510(k) clearance process.
This is also an issue important to Memphis. (See “New FDA Rules Could Tighten Medical Device Pipeline” in the Feb. 24 edition of The Daily News.)
www.memphisdailynews.com/editorial/Article.aspx?id=48085
Representatives of the Minnesota Medical Device Alliance met earlier this month with Dr. Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health division.
Shuren will travel to Mineapolis on May 18 for a town meeting to discuss the proposed changes. Read the article:
www.startribune.com/business/91875939.html?elr=KArks:DCiU1OiP:DiiUiD3aPc:_Yyc:aUU

Wells Fargo

Wells Fargo, the giant lender Memphis and Shelby County governments have sued over allegedly dubious mortgage lending practices, is building its team of attorneys who will defend the company in a Memphis courtroom.

Jennifer Hagerman, an attorney with Burch Porter & Johnson PLLC, is now representing Wells Fargo in the city-county suit. Hagerman is also the chairman of the Center City Commission board of directors.

She joins fellow Burch Porter & Johnson attorney Jef Feibelman in representing Wells Fargo, along with 4 attorneys from Washington D.C., according to the docket of the case.

Dansette

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