Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 245

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 245
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, 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, directly or indirectly
through our customers and partners, to various fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute, U.S.
False Claims Act, and similar state laws, which impact, among other things, our proposed sales, marketing, and scientific/educational
grant programs. If we participate in the U.S. Medicaid Drug Rebate Program, the Federal Supply Schedule of the VA, or other government
drug programs, we will be subject to complex laws and regulations regarding reporting and payment obligations. All of these activities
are also potentially subject to U.S. federal and state consumer protection and unfair competition laws