Review and Revision of Guidances for Industry on the Development of Generic Drug Products; Development and Use of Food and Drug Administration Guidance Documents; Update and Withdrawal of Guidances

摘要

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is updating drug manufacturers on OGD efforts to review policy and procedure guides (PPGs) and other existing OGD documents that provide guidance on the development of generic drug products. We are also announcing the withdrawal of a list of PPGs that have become obsolete or have been replaced with other guidances or agency directives (manuals for policy and procedures (MaPPs)).