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)”.
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Endo Pharmaceuticals Recalls Self-Injected Erectile Dysfunction Drug Due to Concerns Over Sterility
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