Major USFDA Regulatory Updates in December 2022

• On December 02, FDA issued draft guidance on "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions." This guidance provides recommendations to applicants on the content, timing, and assessment of a pre-submission facility correspondence (PFS) within the ANDA submission to fast-track the review of ANDA applications under the provisions of the GDUFA III commitment letter. This guidance replaces the draft guidance "ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug 24 Applications" issued in November 2017.

• On December 02, FDA issued draft guidance on "Statistical Approaches to Establishing Bioequivalence." This guidance provides recommendations to applicants on using equivalence criteria in analyzing in vitro and in vivo bioequivalence studies to support IND, NDA, ANDA, and supplement applications. This guidance also provides recommendations on using statistical approaches in specific situations, such as missing data, intercurrent events, and adaptive clinic trials with highly variable drugs with a low therapeutic index.

• On December 05, FDA issued final guidance on "E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials". This guidance provides recommendations to IND, NDA, and ANDA holders on the selective approaches that may be considered during the collection of safety data from interventional clinical trials, primarily in the post-approval setting (phase 4) and in some circumstances, pre-approval settings (late phase 3). However, this guidance does not apply to clinical trials associated with gene therapy or orphan drug products.

• On December 14, FDA issued final guidance on "Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry." This guidance aims to assist applicants in taking stringent actions when they receive the Complete Response Letter (CRL) upon submission of the ANDA application to the FDA. This guidance also discusses the FDA's enforcement details if applicants fail to submit their response to the CRL in a designated timeframe. This guidance replaces the guidance with the same title issued in July 2022.

• On December 15, FDA issued final guidance on "Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims." This guidance assists NDA and ANDA applicants in defining and developing new labels to claim the clinical benefits of using antihypertensive drugs. Currently, the label claims for antihypertensive medicines only indicate their benefits to lower blood pressure; however, the claims rarely include additional long-term benefits related to preventing cardiovascular events associated with well-maintained blood pressure. This guidance also covers the requirements to file a Prior Approval Supplements (PAS) for the claim.

Note: We acknowledge that there are other FDA updates for December, but we would like to highlight the significant updates only.

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