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First Amendment to the Contract Between the County of Santa Clara and City of Milpitas×21This is the First Amendment to the Contract between the County of Santa Clara (COUNTY) and City of Milpitas
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21 - amendment no refers to amendments made to the food and drug regulations, specifically relating to the review process for new drug applications and safety monitoring in the United States.
Pharmaceutical companies and other entities seeking approval for new drugs or amendments to existing drug applications are required to file 21 - amendment no.
To fill out the 21 - amendment no, applicants must provide detailed information regarding the drug, including clinical study data, manufacturing processes, labeling information, and any changes being made to previously approved applications.
The purpose of 21 - amendment no is to ensure that all changes to drug applications are properly reviewed and evaluated for safety and efficacy by the FDA.
The information reported must include the nature of the amendment, relevant data from clinical trials, updated labeling, manufacturing changes, and any other significant modifications that affect the drug's safety or efficacy.
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