Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 19

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 19
---
 those for which the product was
initially tested and approved. Also, the FDA or other regulatory authorities require post-marketing reporting to monitor the adverse
effects of a drug. Results of post-marketing programs may limit or expand the further marketing of a product.

The FDA closely regulates the
post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion,
industry-sponsored scientific and educational activities and promotional activities involving the Internet. A company can make only those
claims relating to safety and efficacy that are approved by the FDA. Failure to comply with these requirements can result in adverse
publicity, warning letters, corrective advertising, fines and potential civil and criminal penalties.

Section 505(b)(2) New Drug Applications

As an alternate path for FDA
approval of new indications or new formulations of previously-approved products, a company may file a Section 505(b)(2) NDA instead of
a “stand-alone” or “full” NDA. Section 505(b)(2) of the FDCA was enacted as part of the Drug Price Competition
and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Amendments. Section 505(b)(2) permits the submission of
an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for
which the applicant has not obtained a right of reference. Some examples of products that may be allowed to follow a Section 505(b)(2)
path to approval are drugs that have a new dosage form, strength, route of administration, formulation or indication.

The Hatch-Waxman Amendments permit
the applicant to rely upon certain published nonclinical or clinical studies conducted for an approved product or the FDA’s conclusions
from prior review of such studies. The FDA may require companies to perform additional studies or measurements to support any changes
from the approved product. The FDA may then approve the new product for all or some of the labeled indications for which the reference
product has been approved, as well as for any new indication supported by the Section 505(b)(2) application. While references to nonclinical
and clinical data not generated by the applicant or for which the applicant does not have a right of reference are allowed, all development,
process, stability, qualification and validation data related to the manufacturing and quality of the new product must be included in
an NDA submitted under Section 505(b)(2).

To the extent that the Section
505