Recently Posted Guidance Documents on Supply-Chain Program Requirements, CMC, ICH-Efficacy

Supply-Chain Program Requirements  11/3/2017 Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food Administrative / Procedural 11/3/2017  Formal Dispute Resolution: Appeals Above the Division Level Guidance for Industy Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC) 11/3/2017 ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry Generic Drugs, User Fees 11/2/2017  Controlled Correspondence Related to Generic Drug Development Draft Guidance for Industry Premarket;  Labeling, Safety; and Administrative / Procedural 10/30/2017  Acceptance Review for De Novo Classification Requests - Draft Guidance for Industry and Food and Drug Administration Staff 10/30/2017  Product Labeling for Certain Ultrasonic Surgical Aspirator Devices - Guidance for Industry and Food and Drug Administration Staff 10/30/2017 De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff  Postmarket 10/30/2017  Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request - Guidance for Industry and Food and Drug Administration Staff ICH-Efficacy 10/30/2017  E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials