FDA Guidelines For Electronic Submissions For New Product Applications & Clinical Trials Published In Biomedical Market Newsletter.

COSTA MESA, Calif.--(BW HealthWire)--June 25, 1999--

Important new FDA guidelines for electronic submissions have been published in the latest issue of Biomedical Market Newsletter(R).

Although final guidelines are still being developed, a new suggested format + guidance on clinical trials submissions, are in BMN.

This great 60-page Special Issue (May 31, 1999) of BMN begins with the cover story on reimbursement/coverage victories by Endocare and Eclipse Surgical Technologies.

ALSO INCLUDES:

-- Legislative proposals by Health Industry Manufacturers

Association, to improve HCFA/Medicare payment system.

-- Congressional testimony (April 7, 1999) by HIMA boardmember

Walt Rosebrough, President, Hill-Rom.

-- Proposal by Medical Device Manufacturers Association to expand

reimbursement/coverage of investigational devices.

-- Proposal by MDMA for HCFA to hold Town Hall meeting on device

cost effectiveness; criteria for determining appropriate

policies for including medical technologies into Medicare.

-- Medical & Services Industry Outlook, 1999; Age Of Managed Care

Dominates All.

-- Draft Orthopedic Implant Notice Released.

-- 124 PMA Approvals profiled with contact persons, phone, fax,

e-mail & website, January-March 1999.

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