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Investigational New Drug (IND)

Meaning

An Investigational New Drug, or IND, is a formal application submitted to a regulatory authority, such as the U.S. Food and Drug Administration (FDA), seeking permission to administer a new drug to human subjects in clinical trials. This regulatory status allows a pharmaceutical company or sponsor to ship the drug across state lines and conduct clinical research before a marketing application is filed and approved. The IND application must include detailed preclinical data on the drug’s chemistry, manufacturing, and toxicology, along with the proposed clinical protocols and information about the investigators. Securing IND status is the essential first step in the formal clinical development pathway for any novel therapeutic agent.
Rows of uniform vials with white caps, symbolizing dosage precision for peptide therapy and bioidentical hormones. Represents controlled administration for hormone optimization, vital for metabolic health, cellular function, and endocrine regulation in clinical wellness protocols.
What Are the Regulatory Differences between Compounded and Manufactured Peptides?

What Are the Regulatory Differences between Compounded and Manufactured Peptides?

The regulatory path for peptides is defined by their purpose: manufactured drugs undergo extensive FDA trials for broad public safety, while compounded versions are personalized under pharmacy standards for specific patient needs.
∞ Food and Drug Administration
∞ 503a Compounding Pharmacy
∞ Good Manufacturing Practices
HRTio
August 1, 2025