Anavex Life Sciences Corp (AVXL)

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"To A Degree, Flexibility Is Part of FDA Regulation Paradigm (21 CFR 314 (APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG)

Regulations allow for flexibility and judgment in applying the standards, and the FDA has a solid record of appropriately applying regulatory flexibility.

Flexibility

“While the statutory standards apply to all drugs… the many kinds of drugs… and wide range of uses for those drugs demand flexibility in applying the standards.

Thus FDA is required to exercise its scientific judgment to determine the kind and quantity of data and information an applicant is required to provide for a particular drug to meet the statutory standards.” (21 CFR 314.105 Approval of an Application)