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1. Donn LA ooo XmOnn Donnn mn a 2 0 A O00 A 020090 O A Regulatory Focus 14 6 43 45 2009000 0 0 O U U Regulatory Focus 14 8 44 46 2009 3 Gross M 0 0 Regulatory Focus 14 6 43 46 2009 4 21 CFR 3 1 5 OOOO00000000000 OOO000 O0 ICAT 1991 6 00 0 0000 0000 0 00 00 QCDRH 1997 0 50 20 7 00 50 8 FDADIA NI 0000000000000000 2005 50 tonm 9 ooog U U U U U U U 200811 30 0 10 21 CFR 3 2 e 2 0 O MO0000 Douglas Mead Q 0 0 OOOO OO0 U Michael Gross PhD RAC Biologics Consulting Group 0 0 O O00 DOU DO 0 U U O0300 0 FDA 00 0000 U Gross 20 Do 0002. DopononoopoDDopDDDCDDQDQCDODDDQDQDDQDQDDDVM U 0000 DO DOT NONM NANA Non non nn noon n onon onon n non non MO ON DponnnonnoonnoonoDoonDDDDQDDODDQQO 199700 CDRA NM OOO nAfANNNNNMNANNNNNMANNMNNNNANNNNMMMMMAMANMMNMNMI ponp op ooo oppopgpoopgppoppopoppoppDDDQDQODDOD UNI NANA NAA AAA FDANMNMNMNNNMNNNNNANMNMNMMMMNMNNI III III III III MOD DO D DD DO DI NON NON MANNMN MI MN MONN MN AAA ooo nnn NA NMN I Don ooo pp pgoop onp ponpon po pop DDD DOD DO UI NONnnnnnnnnonnnnonono non non Donn NON DON DON MIN DOnonnnDDoDODQDODODNNFDAN MON NDONNDNOOD OO OO II UI nOnnnnnn non non noon OOO AA Non OHT ME non A nNANNNMANNNNNMANNMNNNMNNCDERNNMNMNMMNMNNMNNNNMI NNANNNNNNNNNNMNNNN MN MON MM MNNNM MON MNCDERM CDRHMI MICAN MAN ANNNNNNNANONNANNNN MNNAMMNANMANANMAMNMANM DopononpooooopoDopooopoonnDpogCHDCCDDODDDDODDDODDDDOD nOnnnnOnnnnNnnNnNnNNn nn non non nn n NON n NI DounopooopopnpooooonpopopDoDonopopQODDCNDDDQDDDDDODDQD HHI MIN
3. NOnNnNNNNNNN OOOO AANA A Onn non nn non nn ol DopponppDpDoDpppppooDp DpDDDDDDQDQDDDDQDDOUDQDDDDQDI Donn MOND OA NANA ANA NON NON DO NON DON nn LI DoononnnnooooDonooponDDopnDDDDODNDDODMFUNANODODON NO nnnnnNnnnnon monn nnonon mun non non n On DON MONN noponnononorpan OO O0dp00000000000000 000000 DI nOnnnnnnnnnnnonnoMnonnnonnnnon nn nnnnnnQOn NAA ANA NAMANA nn MN NAN NNNNMNCDRA NM MNMNNNNI MAANA NON AAA nn m n n non non no non non Onan NOnNnOnnn non non no ANON ONAN pon on NA MONN IILI NA nnnnnnnOn noon non nn on nonm on mon monn non oDomounonnp mon MODD aaa
4. TMIEMHOM OOOOODOOO000O0O00O0D0OOOUOOO0OOOOOOOFDADOOOOOOOI noon onn onn non onn onon nnnn ponn A00 AHN ponpon oppopouppo Do nDDDQDQDDDDDDDQDQDDDD DI Du DO DI NONnnNnNNNNNNNOn MNNNNNNNNNNNMNANNNNMNMNNNMNMNMNNNI DopoooDonpoopoooopopopoppoopponDopopDDppDgpDDDODHOWI non non On ONI nOnnnnnnnnnnnnnn nn n ANNO NI IILI DO D DLO NA ANAONA FDAN NNNMONMNMI nonnnn
5. ooonoonononDD MOnnon Michael Gross PhD RAC MITI nanananAaAAmDAMANNAANNN 4A NAN nn n DonononoonononnponoonpnppnpoDoDoOooODODODONONDNDODODNM 201 m DN monnnmannnonoon ponn Donn NON non non monn popo pDDDDpDODDDD DU DODDDDDDDD IU DI NOOO OOO 00 0 MFU nonnon non po MON onn INTIMMI DopoonopppDpDDDDppDMODDDDDDDDDDQDLODQDO MIMMOMOMMMI MOT nOFDANNNNNN HHIH II nnom onn onn nn mon nOnnnnonopmononnnnoonnon m oon nonnnnnnnnnononoOn non NON NFDAN OOO nonmonnnI W FDATIIIIIITI DopooocoODDDQDDp0DDOQODDQODDDCCDQDDCOCQOQDQODQDDQDDDDODDOD nan
6. MMMOMAMMOOMMMMNQOAIAMTOMOMMMMMAOMMU NONnnnNnNNNNnNnNnNnno MO nnnonnonon onn onn on on nOnnnnnonnnnnnoonnnnnnnOnn 2008000000 On nonnnNN AN ANNAMANNMM ANN MM NNNN MAN MN A MI NA nn non n nn non DO nn m non n nn n non n nn ONI NONNNNNMNMN MANMNMNNNNNMNMNA NNONNMNMNMNMNMANI HH NAA NAA monn OO noon nn AN NI HOMO nn ni NHOOOON ANA NANA AAA non nn no nn mo non MO nn On nNOnNNnNnNNNNNNnNNNNN NON nn nn m non nn non nn MIMMMMMOQQOMNM MAANA NA NAMANA AAA Non n mo nn n NI MINNOM FDANNNNMANNMNMCDRHN CDER f 2008 30NNNNNMNNNNNNNNNNMNMNNNNMNNMNMNMNNMNMON MMN AN NNA nn ANNMA NNA NFDAN ANNANNNNANNNANMMANNMNMNMNN nOnNnNnnnmonnnnonnnnn on po non non NON MO Mon FUN MNNNNNNNNnNnnnnnnonnn non non nn On AAA AA MM NON nn III THI N2 CFR 3 2 e 3 DODDDDDOUCCCCDDDODDCOUODODCDDDDDDDDQDDDQDOQODI DONN NON MON AN MONN MN MN NM A xXxOoO MN MAN x DDODDDDODCCDUOxDODODODOQDQODDDODOxODODDQDDQDDDQOQOI NANA AAA ifVMOMNNNNNNMNMNMNMNMNMMNMNMMNMNMNMNMNA NM DOUDDDODDODODDOOO MOD OQ xI UUOOUOULLUXI
7. UU nNNANNNNNNNNNNOMNMNNMNMNNANNMN SAA NAN NN MN INDO OO MO n On on mon nn nn nom onon oo nononnonon onn FOAN OOOOH NONNNNNNNNNNNNNNN IfUNNNNNNNNNNM O nNONNNNNNNNNNMNNNNNNN OOOO AA III CDER MI CBER MI MNMNNNNNOMn MANN NNNMNNMONNNNN MN NMNMNNNN MN MN NAA ANA NANA NANA ANAAMINI AAA noon n onon onon nn NANA ANA AAA non NO non On nn non nn nn l POODAO0O0OO0OO0OO0N0OAD0OA000AMA00MAAMMAN0MANHMI NMOOn Monn nonnnnonn no non non onon nn noon nO nOnnnnonnnnonononnnnon non NNNNNNNn n mn n n Don NA NAANAA n On non nn nnnnonon nnnpon nn non MONN MINNOM n NOOOANOOOOOOAAA On n MONN IFUN MI NANA AMANA NANA n n nnnnon THI NI NONNNN MMNNNNNMNMNMMNMNNNMMOMNMNMONMO0NNNMMAN N MO MAANA AAA nnnn m Onnnnomonnon on n mon nonnnnnononnnononDnn mon n nannnnnD NONn NANNNNNNNNMNMNNNMNMNNMNMNMNMNNMMNMNMMMNMNM MONN IAA NAA MON MAN NON nn nn min non NANDI
8. anmanmAannanmannanannanannanananan N MN AMI DonoononnpoooppponnpoonDpDoDnDDDDDQDQOD FDAN DO DONN III MITMUM NOOO NANA NANA mnnnn ANA NA AAA ooo OmAOnn nOnnnnnnnonnnnnnon onn non nn non n On DA MO man nOnnOnNnNNNnNNnNNNnnNnnn onon onn non on pon NO D N nOnnnnonnnon no NnNn nn n UHT n mon NANA NAMANA non onon monn non n no NO MOND on NO MoOnnnonmonnonnn onn non non mon non n NANA nNNANNNNNNNONNNNNNNNNNNNMNNMNMNN21 CFR 201 NNMMNN MN DONN NNNNNNNNNNN n NN NM AN N21 CFR 801 4000 000001 NONNNNNNNNMNMN21 CFR 801 1500 000 00000 MN N21 CFR 801 511 M nOnnnnnonononnnnononnon ponn ponn Dn n nn n HOO onon DON DON DNDNDNDNNDN DO pDD DDN DDDDOD DOM DON NANA ANA NANA nn nn non NANA NANA NA AAA non On NANA NAA ANA NAA NAMANA non non HHIH NONNNNNOMNNMANNNNMNNNNNNNCDRAMNANMNNAMAONMNMNMNMNON CDERTMNNNNNNNNMNMNNMCAN M ANNNNNNNNMNNNNMN 2001
9. mgross bcg usa con Copyright 2009 by the Regulatory Affairs Professionals Society RAPS Reprinted from the October 2009 issue of Regulatory Focus with the permission of RAPS
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