ABD’de jenerik ilaçlarda değişiklik başvurularına yönelik yeni rehber (İng)

 

 

A new guideline (FDA) for internal review staff on how to handle amendments to generic drug applications

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has released a new guideline for its internal review staff on how to handle amendments to generic drug applications.The Manual of Policies and Procedures (MAPP), Reviewer Determination of Major/Minor Amendments to Abbreviated New Drug Applications, is specifically intended for OGD’s chemistry review staff. After submitting an original or supplemental Abbreviated New Drug Application (ANDA), which are used to support approval for generic drugs, companies may file amendments to the application to reflect new information or desired changes.

 

Manual of Policies and Procedures (İndir)

Guidance for Industry (İndir)