Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 89

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 89
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 manufacturing controls. The
cost of preparing and submitting an NDA may be substantial. Under U. S. federal law, the submission of NDAs is generally subject to substantial
application user fees, and the manufacturer and/or sponsor under an NDA approved by the FDA is also subject to annual product and establishment
user fees. These fees are typically increased annually.

The FDA has 60 days from its receipt of an NDA/BLA to determine
whether the application will be accepted for filing based on the FDA threshold determination that the application is sufficiently complete
to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review of the submitted application.
Under U. S. federal law, the FDA has agreed to certain performance goals in the review of NDAs/BLAs. Most such applications for non-priority
drug products are to be reviewed within 10 months following acceptance of the application for filing. The review process may be significantly
extended by FDA requests for additional information or clarification or if the applicant submits a major amendment during the review.
The FDA may also refer applications to an advisory committee, typically a panel that includes clinicians and other experts, for review,
evaluation and a recommendation as to whether the application should be approved. This often, but not exclusively, occurs for novel drug
products or drug products that present difficult questions of safety or efficacy. The FDA is not bound by the recommendation of an advisory
committee.

Before approving an application, the FDA typically will inspect
the facility or facilities where the product is manufactured. The FDA will not approve the application unless the FDA determines that
the product is manufactured in substantial compliance with cGMP. If the FDA determines that the NDA or BLA is supported by adequate data
and information, the FDA may issue an approval letter. During review, the FDA may request additional information via an information request,
or IR letter, or state deficiencies via a deficiency letter, or DR letter. Upon compliance with the conditions stated, the FDA will typically
issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific
indications. As a condition of approval, the FDA may require additional trials or post-approval testing and surveillance to monitor the
drug’s safety or efficacy, the adoption of risk evaluation and mitigation strategies, and may impose other conditions, including
labeling and marketing restrictions on the use of the drug, which can materially affect its potential market and profitability. Once granted,
product approvals may be withdrawn if