Manufacturers seeking FDA approval for a generic drug must demonstrate bioequivalence to the brand-name drug. This means the generic drug must have the same active ingredient, dosage form, strength, and route of administration as the brand-name drug. The FDA rigorously compares the rate and extent of absorption of the generic drug to its brand-name counterpart.
Next, the manufacturer submits a comprehensive application, including data from bioequivalence studies, manufacturing processes, and quality control measures. This application undergoes a thorough review by FDA scientists, who evaluate the safety and efficacy of the generic drug. They examine the chemistry, manufacturing, and controls (CMC) of the generic drug to guarantee manufacturing consistency and quality.
The FDA assesses the proposed labeling for accuracy and clarity, ensuring it properly informs healthcare providers and patients about the drug’s use and potential risks. After a review, the FDA may approve the generic drug or request further data or modifications. This process usually takes 10-18 months and ensures the generic drug meets the same high standards as the original brand-name medication.
Important Note: The FDA’s rigorous review process includes a detailed comparison of the inactive ingredients. While these aren’t expected to affect the drug’s efficacy, the FDA evaluates their potential for causing allergic reactions or other adverse effects. The agency uses a risk-based approach, paying particular attention to components with a history of causing adverse reactions.
Transparency is key: The FDA makes much of its review data publicly available, allowing for scrutiny by other experts and the public. This transparency promotes accountability and trust in the drug approval process.
