Latest Federal Register Notices
DEVICES
Reg Review Period on Medtronic’s Core Valve System
Federal Register Notice: FDA has determined the regulatory review period for Medtronic’s Core Valve System for patent extension purposes — 1,194 days. Of this time, 1,017 days occurred during the testing phase of the regulatory review period, while 177 days occurred during the approval phase. To view the notice, click here.
DRUGS
Draft Guide on Pediatric Clinical Trials
Federal Register Notice: FDA has made available a draft guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” The International Council for Harmonization draft is intended to update the ICH E11 guidance and provide clarification and current regulatory perspective on topics in global pediatric drug development. To view the notice, click here.
Guide on Generic Drug User Fee Questions & Answers
Federal Register Notice: FDA has made available a guidance entitled “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.” The document provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes a revised version of the guidance. To view the guidance, click here. To view the notice, click here.
Reg Review Period on Pharming’s Ruconest
Federal Register Notice: FDA has determined the regulatory review period for Pharming Group’s Ruconest for patent extension purposes — 3,502 days. Of this time, 3,045 days occurred during the testing phase of the regulatory review period, while 457 days occurred during the approval phase. To view the notice, click here.
Guide on CMO Quality Agreements
Federal Register Notice: FDA has made available a guidance entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The document describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current GMP requirements. Specifically, it describes how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure GMP compliance. To view the guidance, click here. To view the notice, click here.
FDA GENERAL
Final Rule on Time and Extent Sunscreen Reviews
Federal Register Final Rule: FDA has amended its nonprescription (over-the-counter or OTC) drug regulations to supplement the time and extent application (TEA) process by establishing timelines and performance metrics for FDA’s review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act. It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient. To view the final rule, click here.
Guide on Sunscreen Data Submissions
Federal Register Notice: FDA has made available a guidance entitled “Nonprescription Sunscreen Drug Products — Format and Content of Data Submissions.” The document provides FDA’s current thinking on the format and content of information provided to support a request for a determination whether a nonprescription sunscreen active ingredient is generally recognized as safe and effective (GRASE). To view the guidance, click here. To view the notice, click here.