fda fsm a explained all candy 0119111

Upload: jessica-angelina

Post on 03-Jun-2018

218 views

Category:

Documents


0 download

TRANSCRIPT

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    1/27

    PHILIP C. OLSSONRICHARD L. FRANKDAVID F. WEEDA (1948-2001)DENNIS R. JOHNSONARTHUR Y. TSIENJOHN W. ODE!STEPHEN D. TER"AN"ARSHALL L. "AT#"ICHAEL J. O$FLAHERTY

    DAVID L. DURKINNEIL F. O$FLAHERTYRETT T. SCHWE"ERTISH E. PAHLROERT A. HAHNEVAN P. PHELPS%ARY H. AISEDAVID A. IE%IN%KATHRYN E. AL"FORDFREDERICK H. RANDIN%!RUCE A. SILVER%LADE

    !PRACTICE WITHIN THE DISTRICT OF COLU"IAIS LI"ITED TO "ATTERS AND PROCEDURESEFORE FEDERAL COURTS AND A%ENCIES

    OLSSONFRANKWEEDATERMANODE "ATZPC

    ATTORNEYS AT LAWS U I T E 4 0 0

    1 4 0 0 S I X T E E N T H S T R E E T , N . W .

    WASHINGT ON, D .C. 20036 (202 ) 7! "1212

    ###.$%#&'#.$

    JOLYDA O. SWAI"JONATHAN ". WEINRIENANCY W. "ATHEWSON

    COUNSEL

    RO%ER R. S#E"RAJANSON ". KELLER

    CASPER E. ULDRIKS!OF COUNSEL

    KENNETH D. ACKER"AN

    "ARK L. IT#KOFFELLIOT ELILOSSENIOR POLICY ADVISORS

    JOHN R. LOCKCHARLES W. STENHOL"

    %EOR%E "&%OVERNSALLY S. DONNERRENT W. %ATTIS

    ARARA J. "ASTERS

    MEMORANDUM

    J''*+ 19, 2011

    *Y ELECTRONIC MAIL

    FRO" O// F*' W3' T*' 3 "'56 PC

    RE T7 FDA F3 S'5+ "3*6'5 A&5

    T7 :FDA F3 S'5+ "3*6'5 A&5 2010; (P

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    2/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 2

    R@/5*'5 '3 I/&5

    F3 '&5/ '* **3 5 *@/5* =57 FDA

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    3/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ >

    F/

    F3 '&5/ '3 3 *5*/ '* /

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    4/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 4

    '&7 -

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    5/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ ?

    =@ 5/ 7'6'*3 ''+//, *5 &5*/ (&3@ *5 &5*/ '5 &*5&'&5* 5/, '+), 5*@, *&'5, &**&5 '&5/, '3 *&*3@.

    Re(!ired Elements

    +a,ard analsis- "/5 35+ '3 ''5 ' = * *'/'

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    6/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@

    Verification- "/5 *+ 57'5 57 '&5+/ *5 &5*/ '* '3'5 5 &5* 57

    7'6'*3/ 353 57 7'6'*3 ''+//, 57'5 5*@ /

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    7/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@

    o FDA '+,

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    8/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 8

    5'*@5@ /&5/ *@ '&5/, FDA = &/3* '*5&'5 57V5'*+ '3 I*5* P*@*' '3 57*3-'*5+ &*5&'5.

    +i$& Ris/

    FDA / **3 5 '&'5 */*&/ * /&5 '&&*3@ 5 */, '3 5 35+ 7@7-*/'&5/

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    9/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 9

    I/ 57 '&5+ '353

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    10/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 10

    3/@'53 /&5*/, 3 * 57'5 *@ /5'F* *// S&5 80, ' :*5*; / 33 '/ :57 */ 57'5

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    11/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 11

    *@ '&5/ '3 *53 3/ (=) ('*@ '

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    12/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 12

    W7

    T7/ **5 =

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    13/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 1>

    I FDA 35*/ 57'5 57 3 /'5+ *@*'/, /+/5/, '3 /5'3'*3/ ' *@

    &5*+, 5**5*+, * *@ '* '3'5 5 /* /'5+, FDA / **3 5 35+ /&7'3'&/ '3 /5'

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    14/27

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    15/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 1?

    FDA / **3 5 // *@'5/ 5 *5&5 '@'/5 &&5/ 5*/5

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    16/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 1

    + 57 3 2012, FDA / **3 /5'

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    17/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 1

    o T /*5 *' * ' I*5 A*5M

    o T &+ =57 ' /&& 5/5@ **5 3* 57 FDC A&5 * FDA

    *@'5/ 5 '33*// ' 353 * //&53 3 /'5+ *

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    18/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 18

    FDA / '/ **3 5 // *@'5/ &5'@ = *&*3@ **5/ '&'?0&)'3 FDA *@'5/ '5 21 C.F.R. P'*5 1, S

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    19/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 19

    3/ '* 5 33 5 *5&5

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    20/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 20

    NCA

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    21/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 21

    I, '5* *3@ ' *55+ * ' *' 7'*@, FDA 35*/ 57 3 /73

    D$ A5=$

    o A '*5& 3 *3 * *5 /7'

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    24/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 24

    A '' * 57 *//

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    25/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 2?

    XIII. OTHER +ROISIONS O/ INTEREST

    W=8&?&$# +$$

    T7 FS"A '33/ ' = S&5 1012 5 57 FDC A&5 (21 U.S.C. >99&) 57'5 *3/:=7/5

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    26/27

  • 8/12/2019 FDA Fsm a Explained All Candy 0119111

    27/27

    OLSSON FRANK WEEDATER"AN ODE "AT# PC

    J''*+ 19, 2011P'@ 2

    o E/5'01 F*@ S* V*&'5 P*@*'

    S&5 >02 V5'*+ '3 I*5* P*@*'

    S&5 >0 A&&*35'5 T7*3-P'*5+ A35*/

    o C&5 5*/5 *5

    o F/ 5