HQ Team
May 21, 2025: The Food and Drug Administration has come out with new product-specific guidances for developing generic drugs and generating evidence to support abbreviated new drug application approvals.
The US drug regulator publishes these guidelines to help facilitate generic drug development, streamline new drug application approvals, and support greater access to safe, effective, and high-quality treatments.
When finalised, the guidelines will describe the agency’s current thinking and recommendations on how to develop generic drug products that are expected to be therapeutically equivalent to specific reference-listed drugs.
“These guidances will streamline generic drug development efforts for a wide range of products, such as providing alternate approaches to more burdensome clinical studies,” said Gregory Smith, Country Director, India Office, Office of Global Operations.
Increase availability
It will “potentially accelerate the availability of important drug products, including more patient-friendly formulations, while maintaining the necessary standards for safety and efficacy,” he said.
Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan, Smith said.
The acceleration of the development and approval of generic drugs also advances the goals of the President’s Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First.
The list of 48 guidances (34 new and 14 revised) contains 37 recommendations for products with approved abbreviated new drug applications, including six complex products.
Bronchoconstriction
It also has 13 PSGs for complex products used for the treatment of postpartum depression and Duchenne muscular dystrophy.
Additional guidances include reference products used for the treatment of conditions such as bronchoconstriction, asthma, chronic obstructive pulmonary disease, allergic reactions, and other conditions. The FDA will consider comments to the public docket before finalising the guidances.
The regulator also posted new and revised PSGs under development and includes the planned revision categories and brief descriptions of the revisions on its “Upcoming Product-Specific Guidances for Generic Drug Product Development” web page.
Teleconferencing
Under the GDUFA III Commitment Letter, eligible applicants may request a product-specific guidance teleconference to obtain FDA’s feedback on the potential impact of a new or revised guidance on its development program and a subsequent product-specific guidance meeting following feedback received at the teleconference.
Important guidelines in this list include guidelines for the treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma, albuterol sulfate and budesonide inhalation metered aerosol.
It also added new guidance for maintenance treatment of chronic obstructive pulmonary disease, budesonide, and formoterol fumarate inhalation metered aerosol.
