Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 51

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 51
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in accordance with Good Clinical Practice (“ GCP”) guidelines and the investigational plan and protocols contained
in an Investigational New Drug (“IND”) application, or comparable foreign regulatory submission. Set forth below is
a brief summary of the material governmental regulations affecting us in the major markets in which we intend to market our products
and/or promote products that we acquire or in-license or to which we obtain promotional rights.

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The United States. In the U. S., the FDA’s
Center for Drug Evaluation and Research (“ CDER”) under the Federal Food, Drug and Cosmetic Act of 1938, as amended
(the “ FDCA”), the Public Health Service Act and other federal statutes and regulations, subjects pharmaceutical products
to rigorous review. In order to market and sell a new drug product in the U. S., we must first test it and send CDER evidence from these
tests to prove that the drug is safe and effective for its intended use. In most cases, these tests include extensive preclinical, clinical,
and laboratory tests. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists review the company’s
data and proposed labeling. If this independent and unbiased review establishes that a drug’s health benefits outweigh its known
risks, the drug is approved for sale. CDER does not test the drug itself, but it does conduct limited research in the areas of drug quality,
safety, and effectiveness standards. Before approving a new drug or marketing application, the FDA may conduct pre-approval inspections
of the developer of the drug (the “ sponsor”), its CRO and/or its clinical trial sites to ensure that clinical, safety,
quality control, and other regulated activities are compliant with GCP, or Good Laboratory Practices (“ GLP”), for
specific non-clinical toxicology studies. The manufacturing process, which must be compliant with GMP, and the manufacturing facilities
used to produce a product are also subject to ongoing inspection by the FDA. The FDA may also require confirmatory trials, post-marketing
testing, and/or extra surveillance to monitor the effects of approved products, or place conditions on any approvals that could restrict
the commercial applications of a product. Once approved, the labeling, advertising, promotion, marketing, and distribution of a drug
or biologic product must be in compliance with FDA regulatory requirements.

The first stage required for ultimate FDA approval
of a new biologic or drug involves completion of preclinical studies whereby a sponsor must test new drugs