02570nam 2200553 a 450 991082981340332120230721005128.01-282-02803-097866120280380-470-45618-30-470-45617-5(CKB)1000000000719648(EBL)427883(OCoLC)476271242(SSID)ssj0000166504(PQKBManifestationID)11163359(PQKBTitleCode)TC0000166504(PQKBWorkID)10162264(PQKB)11007696(MiAaPQ)EBC427883(EXLCZ)99100000000071964820081022d2009 uy 0engur|n|---|||||txtccrGuidebook for drug regulatory submissions[electronic resource] /Sandy WeinbergHoboken, N.J. John Wileyc20091 online resource (392 p.)Description based upon print version of record.0-470-37138-2 Includes bibliographical references and index.Ten 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. 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, toolDrugsLaw and legislationUnited StatesDrug approvalUnited StatesDrugsLaw and legislationDrug approval344.7304/233344.7304233Weinberg Sandy1950-1649779MiAaPQMiAaPQMiAaPQBOOK9910829813403321Guidebook for drug regulatory submissions3998727UNINA