Overview:

To facilitate the development and production of generic drugs by the pharmaceutical industry, the FDA has published specific guidelines for the development of generic drugs (PSGs).

Introduction:

The PSGs provide recommendations for generic drug development and generate the evidence needed to support abbreviated approval of new drug applications (ANDA), helping to streamline generic product development and ANDA evaluation. FDA publishes PSGs to help facilitate generic drug competition, supporting greater access to safe, effective, and potentially lower-cost treatments. Improving patient access to high-quality, affordable medicines supports the Agency’s mission to advance public health.

Product-specific guidances (PSGs)includes:

  • Products without approved ANDAs (non-complex products).
  • Products used to treat rare genetic diseases, HIV, severe hypoglycemia, and other conditions.
  • Many products have been supported by the science and research of the Generic Drug User Fee Amendments (GDUFA), such as adult periodontitis.

Blog: Updated – Upcoming Complex PSGs

FDA updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which provides information about the agency’s plans for issuing new or revised PSGs in the coming year for complex generic drug products as defined in the GDUFA II Commitment Letter.

For more Information, see the Product-specific Guidelines.:

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