| Record ID | marc_columbia/Columbia-extract-20221130-009.mrc:352901101:2502 |
| Source | marc_columbia |
| Download Link | /show-records/marc_columbia/Columbia-extract-20221130-009.mrc:352901101:2502?format=raw |
LEADER: 02502pam a22003734a 4500
001 4322759
005 20221102194547.0
008 030807t20042004flua b 001 0 eng
010 $a 2003055779
020 $a1587160072
035 $a(OCoLC)ocm52846639
035 $a(NNC)4322759
035 $a4322759
040 $aDLC$cDLC$dYDX$dNNC-M$dOrLoB-B
042 $apcc
043 $an-us---
050 00 $aRM301.25$b.F37 2004
082 00 $a615/.19/00973$222
245 00 $aFDA regulatory affairs :$ba guide for prescription drugs, medical devices, and biologics /$cedited by Douglas J. Pisano, David Mantus.
260 $aBoca Raton :$bCRC Press,$c[2004], ©2004.
300 $a360 pages :$billustrations ;$c24 cm
336 $atext$btxt$2rdacontent
337 $aunmediated$bn$2rdamedia
504 $aIncludes bibliographical references and index.
505 00 $g1.$tOverview of Drug Development and the FDA /$rDouglas J. Pisano -- $g2.$tRegulatory Strategy /$rJacqueline A. Dombroski -- $g3.$tWhat Is an IND? /$rRobert G. Pietrusko and Thomas Class -- $g4.$tFormatting, Assembling, and Submitting the New Drug Application (NDA) /$rDavid J. Pizzi and Janet C. Rae -- $g5.$tMeeting with the FDA /$rAlberto Grignolo -- $g6.$tBiologics /$rJames G. Kenimer and John J. Jessop -- $g7.$tFDA Medical Device Regulation /$rBarry Sall -- $g8.$tThe Development of Orphan Drugs /$rMarlene V. Haffner -- $g9.$tGood Clinical Practices /$rRobert Buckley -- $g10.$tGood Manufacturing Practices (GMPs) and Enforcement Actions /$rCatherine A. Hay and Horence A. Kaltovich -- $g11.$tElectronic Submissions: A Guide for Electronic Regulatory Submissions to the FDA /$rShylendra Kumar and Vahe Ghahraman -- $g12.$tThe Practice of Regulatory Affairs /$rDavid S. Mantus -- $g13.$tA Primer of Drug/Device Law or What's the Law and How Do I Find It? /$rJosephine C. Babiarz.
610 10 $aUnited States.$bFood and Drug Administration$vRules and practice.
650 0 $aDrug development$zUnited States.
650 0 $aPharmaceutical industry$zUnited States.$0http://id.loc.gov/authorities/subjects/sh2008108871
650 12 $aPharmaceutical Preparations.$0https://id.nlm.nih.gov/mesh/D004364
650 12 $aDrug Industry.$0https://id.nlm.nih.gov/mesh/D004345
651 2 $aUnited States.$0https://id.nlm.nih.gov/mesh/D014481
700 1 $aPisano, Douglas J.$0http://id.loc.gov/authorities/names/n00121754
700 1 $aMantus, David.$0http://id.loc.gov/authorities/names/n2003005480
852 00 $boff,hsl$hRM301.25$i.F37 2004