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In This Issue
Chairman's Message
FMMC New Contact Information
July Executive Meeting
Capitol Notes -Legislative Update
GE Healthcare Closes Tampa Office
LGGS Celebrates Anniversary
FDA Law Blog - ACCESS Act Reintroduced by Senator
Brownback
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FMMC NEW CONTACT INFORMATION
FMMC has a new
office! Please contact and send all correspondence to the
location below:
325 John Knox Rd
Suite L103
Tallahassee, FL 32303
(866) 437-6534 phone
(850) 222-3019
fax
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2008 FMMC Board of Directors
Geary
Havran
Chairman
NDH Medical
Alex Stearns
Treasurer
ETI, Incorporated
Suzanne Christman
Secretary
Pinellas County Economic Development
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FMMC 2009 Symposium
Mark your
calendars for FMMC's 2009 Symposium on April 7th & 8th at the Tampa
Marriott Waterside Hotel & Marina. Be on the lookout for
more information via email or check for updates on FMMC's website at
www.FlaMedMfg.org
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Chairman's Message
Greetings!
I am pleased to report on a number of new activities
undertaken by the FMMC over the last several weeks. In this
newsletter, you will see that the Consortium has a new office staffed
with professional association management and has been relocated to
Tallahassee to better reflect our role as a statewide association and
to have access to the legislative and regulatory bodies of the state
government. Speaking of the government, please review the
Capital Notes section provided by board member John
Ray and a new feature including information from the FDA
Law Blog written by attorneys of Hyman, Phelps & McNamara
P.C. This insight into FDA law related matters is courtesy of
the law firm. We are also pleased to announce that we are beginning a
regular schedule of bi-monthly Executive Briefings. The first
of the series will provide some interesting insight into the way in
which investors and Wall Street look at our industry.
As always, I would like to remind everyone that the value of our
association is only as good as the participation of our
members. Please forward any comments, suggestions, and offers
to volunteer on our various committees to info@FlaMedMfg.org.
Your insights are greatly appreciated. Lastly let me wish
everyone a very pleasant and safe summer.
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July Executive Meeting
Please join
FMMC for our July Executive Meeting!
A special
thank you to our July Executive Meeting Sponsor
Date: July 22nd,
2008
Location: Feather
Sound Country
Club
Address: 2201 Feather
Sound Dr, Clearwater, FL
Time: Registration
and Networking 7:30 - 8:00 AM
Meeting: 8:00 - 9:00
AM
Speaker: Jayson
Bedford, Raymond James & Associates
Breakfast
will be provided for all attendees.
Registration
forms will be emailed shortly and available at www.FlaMedMfg.org. |
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The 2008 Legislative Session, which concluded on May
2nd, was dominated by debate and policy decisions in building the
state's $66.2 billion budget. Due to a poor economy and
slumping tax collections, lawmakers were forced to make a record $5
billion in cuts --- and the burden and pain was shared in all areas
of the budget. Still, the Legislature found a way to preserve and
find new funding for some of Florida's key economic development and
workforce training programs... More |
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GE Healthcare Closes Tampa
Office
GE
Healthcare is closing their Tampa office that was formerly the
Critikon division of Johnson & Johnson. As a result, there
are several employees who will be impacted and are looking for new
career opportunities. Most of the staff are technical
employees. Companies that may have a need for new staff can
obtain additional information by contacting Helen Galletly with Right
Management
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Membership Spotlight
LGGS of Florida (FMMC
Member), located in Groveland, FL, recently celebrated it's First
Anniversary here in the Sunshine State. LGGS is an Anaheim, CA, based
independent testing lab that specializes in Microbial Testing for the
Medical Device Industry. The state of the art Groveland lab serves as
the company's East Coast facility. LGGS performs Bioburden testing,
Sterility testing, EtO Residual testing, Clean Room Environmental
Surveys, Packaging Material testing, and general Micro testing. The
company is dedicated to maintaining ongoing relationships with it's
customers and performs dose audits and validation studies
routinely. |
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ACCESS Act
Reintroduced by Sen. Brownback; Previous Tiered Approval Nomenclature
Scrapped and New Immunity Provision Added
From the FDA Law Blog produced by Hyman, Phelps & McNamara,
P.C.
In late May, Senator Sam Brownback (R-KS) introduced
S. 3046 - the "Access, Compassion, Care, and Ethics for
Seriously Ill Patients Act" (the "ACCESS Act").
The bill, which is similar to legislation Sen. Brownback introduced
in the 109th Congress with the same title (i.e., S. 1956), is
intended to increase terminally ill patients' access to
investigational therapies (i.e., drugs, biological products, and
medical devices) prior to FDA approval or clearance, and is one
component of the ongoing debate over patient access to
investigational therapies More
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