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''Medical Device FDA Review Time'' study released.


COSTA MESA Costa Mesa (kŏs`tə mā`sə), city (1990 pop. 96,357), Orange co., S Calif., on the Pacific south of Santa Ana; inc. 1953. It is a transportation, residential, and light industrial center. , Calif.--(BUSINESS WIRE)--Dec. 18, 1995--A controversial study on Food and Drug Administration medical device reviews, released Oct. 30 by the U.S. General Accounting Office, disputes many important FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 assertions.

Congress ordered the study, ``Medical Device FDA Review Time.''

Biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 Market Newsletter Inc. is distributing it as an 87-page bound volume with an additional special 32-page free bonus section. It has related news articles, FDA statistics and advice columns published recently in BMN BMN Biomednet (former website)
BMN Burke Mountain Naturalists
BMN Berenstein-Maldacena-Nastase (matrix model)
BMN Brand Medically Necessary
BMN Benesh Movement Notation
BMN Building Management Network
.

``The extraordinary study is a real eye opener Opener may refer to:
  • Opening batsman in the game of cricket
  • Conversation opener or pick-up line
  • Opener (8mm album)
Openers may refer to the plural of 'opener', or to:
 and must read. It contradicts many FDA claims about product approval times, thereby supporting previous claims of some companies,'' noted medical industry authority David Anast, publisher, Biomedical Market Newsletter.

Order by phone or fax for same-day shipment via First Class U.S. mail. Order one individually or as part of a set of five bound FDA manuals. Orders by Jan. 1 receive one free sample issue of BMN ($55 value) while supplies last.

Special offer pre-payment prices: one copy: $45 + $5 s/h ($10 foreign) + tax. Five-volume set: $195 (regular $45 each; save $30) + s/h + tax. Bought separately: $45 each (+ $5 shipping each + 7.75 percent tax for California residents only). Two or more copies (any combination, ordered at same time): $40 each. Invoicing in·voice  
n.
1. A detailed list of goods shipped or services rendered, with an account of all costs; an itemized bill.

2. The goods or services itemized in an invoice.

tr.v.
: $25 extra. Purchase orders: Not accepted. Pre-payment: Required.

BMN Inc., 3237 Idaho Place, Costa Mesa, Calif. 92626-2207; 800/875-8181; 714/434-9500 phone; 714/434-9755 fax. -0- ____________________________________________________________________ FDA MANUALS Fax Order Form To: 714/434-9755 Attn: Circulation Dept.

Quantity Manual Date

_________ ``Compliance Program Guidance Manual'' 5/95

``Deciding When To Submit 510(k)s For _________ Changes to Existing Devices'' 8/95

``Federal Food, Drug & Cosmetic cosmetic /cos·met·ic/ (koz-met´ik)
1. pertaining to cosmesis.

2. a beautifying substance or preparation.


cos·met·ic
n.
 Act, _________ As Amended'' 7/93

_________ ``Medical Device FDA Review Time'' 10/95

``Working Draft Final Rule of FDA's _________ Current Good Manufacturing Practice'' 7/95

Prices: $195 for all five manuals bought at the same time

$45 for one; $40 each for 2-5 (at same time, any

combination); $35 each 6-9; $25 each 10+ Shipping: $5 each for 1-5 copies; $3 each for 6+; non-U.S.

shipping is $10 each Sales Tax sales tax, levy on the sale of goods or services, generally calculated as a percentage of the selling price, and sometimes called a purchase tax. It is usually collected in the form of an extra charge by the retailer, who remits the tax to the government. : +7.75 percent sales tax for California residents only

No. copies: Cost: Shipping/Handling: Tax: Total: $

Discover/Visa/Master/Amex no.: Expires:

Name:

Position Title:

Company:

Address:

City: State: Zip Code zip code

System of postal-zone codes (zip stands for “zone improvement plan”) introduced in the U.S. in 1963 to improve mail delivery and exploit electronic reading and sorting capabilities.
:

Phone: Fax: ____________________________________________________________________ -0-

CONTACT: Biomedical Market Newsletter, Costa Mesa

Dave Anast, 714/434-9500
COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Article Details
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Publication:Business Wire
Date:Dec 18, 1995
Words:388
Previous Article:Citation Corporation announces sales for October and November 1995.
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