MARC Record from marc_columbia

LEADER: 02880cam a22004934a 4500
001 7155224
005 20090424115752.0
008 080327s2008 nyua b 001 0 eng
010 $a 2008014296
035 $a(OCoLC)ocn217263645
040 $aDNLM/DLC$cDLC$dNLM$dYDXCP$dBAKER$dBTCTA$dC#P$dCDX$dBWX
016 7 $a101469952$2DNLM
019 $a176987041
020 $a9781420073546 (hbk. : alk. paper)
020 $a1420073540 (hbk. : alk. paper)
029 1 $aNLM$b101469952
029 1 $aAU@$b000042916329
035 $a(OCoLC)217263645$z(OCoLC)176987041
042 $apcc
043 $an-us---
050 00 $aRM301.25$b.F37 2008
060 00 $a2008 L-929
060 10 $aQV 771$bF287 2008
082 00 $a615/.19$222
049 $aZCHA
245 00 $aFDA regulatory affairs :$ba guide for prescription drugs, medical devices, and biologics /$cedited by Douglas J. Pisano, David S. Mantus.
250 $a2nd ed.
260 $aNew York :$bInforma Healthcare USA,$cc2008.
300 $aviii, 448 p. :$bill. ;$c24 cm.
504 $aIncludes bibliographical references and index.
505 0 $aOverview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahé Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer.
650 0 $aDrug development$zUnited States.
610 10 $aUnited States.$bFood and Drug Administration$vRules and practice.
650 0 $aPharmaceutical industry$zUnited States.
610 12 $aUnited States.$bFood and Drug Administration.
650 12 $aDrug Approval$zUnited States.
650 12 $aUnited States Government Agencies$zUnited States.
650 22 $aBiological Products$xstandards$zUnited States.
650 22 $aEquipment and Supplies$xstandards$zUnited States.
650 22 $aGovernment Regulation$zUnited States.
700 1 $aPisano, Douglas J.
700 1 $aMantus, David.
856 42 $3Publisher description$uhttp://www.loc.gov/catdir/enhancements/fy0829/2008014296-d.html
852 00 $bhsl,ref$hRM301.25$i.F37 2008