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FDA review of drug applications / / Morris Cooperman and Richard J. Porter, editors
| FDA review of drug applications / / Morris Cooperman and Richard J. Porter, editors |
| Pubbl/distr/stampa | New York : , : Nova Science Publishers, Incorporated, , [2013] |
| Descrizione fisica | 1 online resource (97 pages) : illustrations |
| Disciplina | 344.7304233 |
| Collana | Government procedures and operations |
| Soggetto topico | Pharmaceutical policy - United States |
| ISBN | 1-62257-772-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Prescription Drug User Fee Act (PDUFA): issues for reauthorization (PDUFA V) in 2012 / Susan Thaul -- Prescription drugs: FDA has met most performance goals for reviewing applications / United States Government Accountability Office. |
| Record Nr. | UNINA-9910148707803321 |
| New York : , : Nova Science Publishers, Incorporated, , [2013] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidebook for drug regulatory submissions [[electronic resource] /] / Sandy Weinberg
| Guidebook for drug regulatory submissions [[electronic resource] /] / Sandy Weinberg |
| Autore | Weinberg Sandy <1950-> |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley, c2009 |
| Descrizione fisica | 1 online resource (392 p.) |
| Disciplina |
344.7304/233
344.7304233 |
| Soggetto topico |
Drugs - Law and legislation - United States
Drug approval - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-282-02803-0
9786612028038 0-470-45618-3 0-470-45617-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9910145952203321 |
Weinberg Sandy <1950->
|
||
| Hoboken, N.J., : John Wiley, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidebook for drug regulatory submissions [[electronic resource] /] / Sandy Weinberg
| Guidebook for drug regulatory submissions [[electronic resource] /] / Sandy Weinberg |
| Autore | Weinberg Sandy <1950-> |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley, c2009 |
| Descrizione fisica | 1 online resource (392 p.) |
| Disciplina |
344.7304/233
344.7304233 |
| Soggetto topico |
Drugs - Law and legislation - United States
Drug approval - United States |
| ISBN |
1-282-02803-0
9786612028038 0-470-45618-3 0-470-45617-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9910829813403321 |
|
Weinberg Sandy <1950->
|
||
| Hoboken, N.J., : John Wiley, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||