FDA publishes product-specific guidances to facilitate generic drug development

FDA publishes product-specific guidances to facilitate generic drug development

June 3, 2020 Off By Dino Mustafić

FDA published on Wednesday a new batch of product-specific guidances (PSGs), providing recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval.

In turn, this is aimed for helping to streamline generic drug product development by industry and ANDA assessment by FDA.
The batch of 69 PSGs includes:  

  • 26 new and 43 revised PSGs
  • PSGs for generic products for important treatments for diseases such as:
  • Human Immunodeficiency Virus (HIV)
  • Leukemia
  • Opioid Use Disorder
  • Post-Partum Depression
  • 36 PSGs for products with no approved ANDAs (including 16 for complex products)
  • 34 PSGs for complex products (10 new and 24 revised)
  • 24 of these PSGs were developed based on research data generated by the Generic Drug User Fee Amendments (GDUFA) Science and Research program

The FDA said that the batch features a new PSG for buprenorphine extended-release subcutaneous solution, which is a long-acting injectable that forms an extended-release implant where it is injected, for treating moderate to severe opioid use disorder. This is the first PSG for a poly(lactide-co-glycolide)- or PLGA-based product and it recommends a single dose parallel design comparative in vivo pharmacokinetic study to demonstrate bioequivalence, FDA said.
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. The FDA noted that the page is updated each time FDA publishes a new batch of PSGs.
The Agency said it 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 noted.

The US FDA reminds that it publishes PSGs to facilitate generic drug development by helping potential applicants efficiently allocate product development resources and prepare more complete submissions. As FDA said, once these products are developed and approved, generic competition could support greater access to high-quality, safe, and effective potentially lower-cost, treatments.
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 said, noting that it considers all comments to the docket before finalizing PSGs.

For more information, to view the guidances, or to submit comments on the PSGs, visit: