LEADER 02570nam 2200553 a 450 001 9910829813403321 005 20230721005128.0 010 $a1-282-02803-0 010 $a9786612028038 010 $a0-470-45618-3 010 $a0-470-45617-5 035 $a(CKB)1000000000719648 035 $a(EBL)427883 035 $a(OCoLC)476271242 035 $a(SSID)ssj0000166504 035 $a(PQKBManifestationID)11163359 035 $a(PQKBTitleCode)TC0000166504 035 $a(PQKBWorkID)10162264 035 $a(PQKB)11007696 035 $a(MiAaPQ)EBC427883 035 $a(EXLCZ)991000000000719648 100 $a20081022d2009 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aGuidebook for drug regulatory submissions$b[electronic resource] /$fSandy Weinberg 210 $aHoboken, N.J. $cJohn Wiley$dc2009 215 $a1 online resource (392 p.) 300 $aDescription based upon print version of record. 311 $a0-470-37138-2 320 $aIncludes bibliographical references and index. 327 $aTen rules for drug regulatory submissions -- FDA meeting requests -- Orphan-drug applications -- Investigational new drug applications (INDs) -- New drug applications (NDAs) -- 505(b)2 new drug applications (NDAs) -- Abbreviated new drug applications (ANDAs) -- Annual reports -- International submissions / Carl A. Rockburne -- Future issues in regulatory submissions. 330 $a Destined to become every regulatory director's essential desktop companion rofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tool 606 $aDrugs$xLaw and legislation$zUnited States 606 $aDrug approval$zUnited States 615 0$aDrugs$xLaw and legislation 615 0$aDrug approval 676 $a344.7304/233 676 $a344.7304233 700 $aWeinberg$b Sandy$f1950-$01649779 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910829813403321 996 $aGuidebook for drug regulatory submissions$93998727 997 $aUNINA