Guidebook for drug regulatory submissions /
Weinberg, Sandy, 1950-
Guidebook for drug regulatory submissions / Sandy Weinberg. - Hoboken, N.J. : Wiley, c2009. - x, 379 p. : ill. ; 25 cm.
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.
9780470371381 0470371382
Drugs--Law and legislation--United States.
Drug approval--United States.
Drug Approval--United States.
Drugs, Investigational--United States.
344.7304233 / W4231g
Guidebook for drug regulatory submissions / Sandy Weinberg. - Hoboken, N.J. : Wiley, c2009. - x, 379 p. : ill. ; 25 cm.
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.
9780470371381 0470371382
Drugs--Law and legislation--United States.
Drug approval--United States.
Drug Approval--United States.
Drugs, Investigational--United States.
344.7304233 / W4231g