Last week, the U.S. Department of Health and Human Services (“HHS”) announced that FDA intends to update its regulations governing clinical studies of new drugs. More specifically, FDA intends to update Parts 312 and 16 of Title 21 of the Code of Federal Regulations (the “Code” or “CFR”). In its announcement, HHS stated that the
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The Scope of FDA’s Proposed Revisions to the IND Regulations May Not Be Sufficient to Achieve Its Stated Goals
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FDA’s Wholesale Distributor and 3PL Reporting Requirements Draft Guidance Provides Some Clarity Not Found in Previous Draft Guidance
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