FDA Amends IND & Bioequivalence Regulations

March 30, 2016

On Monday, March 28th the FDA announced that it is amending its current IND and bioequivalence regulations. Specifically, FDA stated that it is changing “its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER).” Additionally, in order to correct a typo, the Agency is also making a change to its bioequivalence regulations.

The changes to the FDA’s IND regulations involve 21 CFR 312.140(a)(2), which is being amended “by removing ‘CDER Therapeutic Biological Products’ and adding in its place ‘Central’.” Moreover, the address for sponsors to submit INDs is being changed as well. All INDs for biological products will now be submitted to 5901-B Ammendale Rd., Beltsville, MD 20705-1266, rather than the Agency’s Rockville, Maryland address.

The FDA also announced a change to 21 CFR 320.33(f)(3) of its bioequivalence regulations, in which the Agency is removing “(first-class metabolism)” and replacing it with “(first-pass metabolism)”.

FDA’s notice in the Federal Register stated that all changes were made “to ensure accuracy and clarity in the Agency’s regulations,” and are effective immediately.

Are you developing an IND or any other type of FDA submission? We can help. Using our proprietary approach, we have a track record of helping our clients achieve positive outcomes with FDA. To learn more about our services and how we can help you, contact us today.



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