Biograph Inc. Welcomes FDA Draft Guidance to Industry
on Innovative Approaches for Nonprescription Drug Products



(Morristown, NJ) Biograph Inc. commends FDA for the July 17th release of draft guidance to modernize the framework for advancing access to nonprescription drug products. With this draft guidance, the Agency is introducing a new era of healthcare; one in which consumers are empowered and processes are more efficient.


The draft guidance specifically asks industry to consider applying innovative tools, like digital health technologies, to support consumers in appropriately and safely selecting and using certain nonprescription drugs. The guidance confirms that FDA has the authority to include and regulate these innovative approaches in the NDA approval process.


In his statement, Commissioner Scott Gottlieb puts forth the Agency’s intention “to increase access to a broader selection of nonprescription drug products for consumers, empowering them to self-treat common conditions and potentially some chronic conditions”. The Commissioner goes on to say, “select types of drugs are appropriate for nonprescription use if we are able to ensure access to resources that will help patients determine if the medicine is right for them”.


Biograph is dedicated to providing the digital health technologies that can support consumers in safe self-selection and use. The company has had extensive dialogue with FDA through a Pre-RFD process and has proposed solutions which align to the new guidance.


The Biograph technological solution will extend nonprescription access to therapeutic indications that have not been available for use without a prescription, and therefore, to lower cost and improve public health.


We appreciate the invitation to submit comments to FDA and look forward to working with drug developers to begin to study products that might be considered for marketing without a prescription.


Biograph is a digital technology company dedicated to delivering innovative solutions for nonprescription access to drug products.

Ted Lawless


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