FDA seeks input on product-specific guidances to facilitate generic drugdevelopment
Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA.
Today’s batch of 43 PSGs includes:
- 33 new and 10 revised PSGs
- PSGs for generic products for important treatments for diseases such as:
- Amyotrophic Lateral Sclerosis (ALS)
- Diabetes
- Human Immunodeficiency Virus (HIV)
- Lung cancer
- Melanoma
- 38 PSGs for products with no approved ANDAs (including 14 for complex products)
- 16 PSGs for complex products (10 new and 6 revised). 12 of these PSGs were developed based on research data generated by the Generic Drug User Fee Amendments (GDUFA) Science and Research program.
The Agency aims to ensure that policies, regulations, and scientific standards keep pace with the science of equivalence. Improving patient access to high quality and affordable medicines supports FDA’s mission to advance the public health.
FDA publishes PSGs to facilitate generic drug development which helps potential applicants efficiently allocate product development resources and prepare more complete submissions. Once these generic products are developed and approved, the generic competition could support greater access to high-quality, safe, and effective potentially lower-cost, treatments.
GDUFA-funded science and research, which is an important part of FDA’s generic drug program, supports our regulatory decision-making through the development of PSGs. Research that the Agency conducts advances the science of generic drugs and provides generic drug developers, applicants, and FDA assessors essential tools and information to help expedite the development and approval of generic drugs, especially for complex products, which are often more difficult to develop.
When finalized, these guidances will describe the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the docket before finalizing PSGs.
Today, FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which provides information about FDA’s plans for issuing new or revised PSGs in the coming year for complex products as defined in our GDUFA II Commitment Letter. This page is updated each time FDA publishes a new batch of PSGs.
For more information, to view the guidances, or to submit comments on the PSGs, visit:
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