Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 65

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 65
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 to varying site characteristics, such as local standards of care, differences in evaluation period and surgical
technique, and due to varying patient characteristics including demographic factors and health status.

Even if we obtain marketing approval for any
of our drug candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional
expense. Additionally, our drug candidates could be subject to labeling and other restrictions and withdrawal from the market and we
may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our drug
candidates. 

Even if we obtain regulatory
approval for any of our drug candidates for an indication, the FDA or foreign equivalent may still impose significant restrictions on
their indicated uses or marketing or the conditions of approval, or impose ongoing requirements for potentially costly and time-consuming
post-approval studies, including Phase 4 clinical trials, and post-market surveillance to monitor safety and efficacy. Our drug candidates
will also be subject to ongoing regulatory requirements governing the manufacturing, labeling, packaging, storage, distribution, safety
surveillance, advertising, promotion, recordkeeping and reporting of adverse events and other post-market information. These requirements
include registration with the FDA, as well as continued compliance with current Good Clinical Practices regulations (“cGCPs”)
for any clinical trials that we conduct post-approval. In addition, manufacturers of drug products and their facilities are subject to
continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current cGMPs, requirements
relating to quality control, quality assurance and corresponding maintenance of records and documents.

The FDA has the authority to
require a REMS as part of an NDA or after approval, which may impose further requirements or restrictions on the distribution or use
of an approved drug, such as limiting prescribing to certain physicians or medical centers that have undergone specialized training,
limiting treatment to patients who meet certain safe-use criteria or requiring patient testing, monitoring and/or enrollment in a registry.

With respect to sales and marketing
activities by us or any future partner, advertising and promotional materials must comply with FDA rules in addition to other applicable
federal, state and local laws in the U.S. and similar legal requirements in other countries. In the U.S., the distribution of product
samples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. Application holders must obtain
FDA approval for product and manufacturing changes, depending on the nature of the change. We may also be subject