Zdrowie i gospodarka · 02/08/2013
FDA Releases Draft Guidance on Bioequivalence Recommendations for Mesalamine Rectal Suppositories
The FDA has made available a draft guidance document outlining specific recommendations for designing bioequivalence studies to support the approval of mesalamine rectal suppositories through abbreviated new drug applications (ANDAs)
Source: Federal Register — Food and Drug AdministrationOpen original release →