We use cookies to personalise content and ads, to provide social media features and to analyse traffic. We share info about use of our site with social media, ads and analytics partners. By continuing to browse you are agreeing to use of cookies. See details or close this message.

Page

100%

Specifications
Business section

PREVIOUS EDITION IS OBSOLETE.PAGE 1 OF 2 FormApproved:OMBNo.0910-0014. ExpirationDate: May 31, 2009 SeeOMBStatementonReverse.

Specifications
Suggested Link Details/Purchase
Content	PREVIOUS EDITION IS OBSOLETE.PAGE 1 OF 2 FormApproved:OMBNo.0910-0014. ExpirationDate: May 31, 2009 SeeOMBStatementonReverse. (Specify) SERIAL NUMBER NOTE:Nodrugmaybeshippedorclinical investigationbegununtilanINDforthat investigationisineffect(21CFR312.40). 3.ADDRESS(Number,Street,City,StateandZipCode)4.TELEPHONENUMBER (IncludeAreaCode) 7.INDICATION(S)(Coveredbythissubmission) 5.NAME(S)OFDRUG(Includeallavailablenames:Trade,Generic,Chemical,Code) DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION INVESTIGATIONAL NEW DRUG APPLICATION (IND) (TITLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART 312) PSC Media Arts (301) 443-1090 6.INDNUMBER(Ifpreviouslyassigned) 1.NAMEOFSPONSOR2.DATEOFSUBMISSION 8.PHASE(S)OFCLINICALINVESTIGATIONTOBECONDUCTED: 10.INDsubmissionshouldbeconsecutivelynumbered.TheinitialINDshouldbenumbered Serialnumber:0000. Thenextsubmission(e.g.,amendment,report,orcorrespondence)shouldbenumbered SerialNumber:0001. Subsequentsubmissionsshouldbenumberedconsecutivelyintheorderinwhichtheyaresubmitted. 9.LISTNUMBERSOFALLINVESTIGATIONALNEWDRUGAPPLICATIONS(21CFRPart312),NEWDRUGORANTIBIOTICAPPLICATIONS (21CFRPart314),DRUGMASTERFILES(21CFRPart314.420),ANDPRODUCTLICENSEAPPLICATIONS(21CFRPart601)REFERRED TOINTHISAPPLICATION. 11.THISSUBMISSIONCONTAINSTHEFOLLOWING:(Checkallthatapply) INITIALINVESTIGATIONALNEWDRUGAPPLICATION(IND)RESPONSETOCLINICALHOLD PROTOCOLAMENDMENT(S):INFORMATIONAMENDMENT(S):INDSAFETYREPORT(S): NEWPROTOCOLCHEMISTRY/MICROBIOLOGYINITIALWRITTENREPORT CHANGEINPROTOCOLPHARMACOLOGY/TOXICOLOGYFOLLOW-UPTOAWRITTENREPORT NEWINVESTIGATORCLINICAL RESPONSETOFDAREQUESTFORINFORMATIONANNUALREPORTGENERALCORRESPONDENCE DIVISIONASSIGNMENT: FOR FDA USE ONLY JUSTIFICATIONSTATEMENTMUSTBESUBMITTEDWITHAPPLICATIONFORANYCHECKEDBELOW.REFERTOTHECITEDCFRSECTIONFORFURTHERINFORMATION. TREATMENTIND21CFR312.35(b)TREATMENTPROTOCOL21CFR312.35(a)CHARGEREQUEST/NOTIFICATION21CFR312.7(d) CHECK ONLY IF APPLICABLE REQUESTFORREINSTATEMENTOFINDTHATISWITHDRAWN,OTHER INACTIVATED,TERMINATEDORDISCONTINUED DDRRECEIPTSTAMP INDNUMBERASSIGNED: (Specify) OTHERPHASE1PHASE2PHASE3 EFFORM FDA 1571 (4/06) CDR/DBIND/DGDRECEIPTSTAMP Next Page Export DataImport Data Reset Form Next Page Reset FormExport DataImport Data Next Page Export DataImport Data Reset Form Next Page Reset FormExport DataImport Data
Navigation	Previous Page / Next Page
Following Datasheets	UCM083558_1 (2 pages) UCM083570_1 (1 pages) ucm085819_1 (3 pages) UCM086233_1 (46 pages) ucm089021_1 (4 pages) ucm089809_1 (6 pages) ucm089823_1 (3 pages) UCM094979_1 (4 pages) UCM095018_1 (4 pages) UCM113945 (1 pages)
Check in e-portals	World-H-News Products Extensions Partners Automation Jet Parts
Sitemap Folder	group1 group2 group3 group4 group5 group6 group7 group8 group9 group10 group11 group12 group13 group14 group15 group16 group17 group18 group19 group20 group21 group22 group23 group24 group25 group26 group27 group28 group29 group30 group31 group32 group33 group34 group35 group36 group37 group38 group39 group40 group41 group42 group43 group44 group45 group46 group47 group48 group49 group50 group51 group52 group53 group54 group55 group56 group57 group58 group59 group60 group61 group62 group63 group64 group65 group66 group67 group68 group69 group70 group71 group72 group73 group74 group75 group76 group77 group78 group79 group80 group81 group82 group83 group84 group85 group86 group87 group88 group89 group90 group91 group92 group93 group94 group95 group96 group97 group98 group99 group100 Prewious Folder Next Folder