• GMPs for Combination Products, December 22, 2009, Closing Date -- FDA is seeking comments on its proposed rule to codify current good manufacturing practice (cGMP) requirements for combination products.  
  • Structured Product Labeling for Drugs & Biologics, December 28, 2009, Closing Date -- FDA is seeking comments on its draft guidance entitled "SPL Standard for Content of Labeling Technical Qs & As."  
  • Format and Content of REMS, December 30, 2009, Closing Date -- FDA is seeking comments on its draft guidance entitled "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications," which describes the format and content of a proposed risk evaluation and mitigation strategy, including REMS supporting documentation, the content of assessments and proposed modifications of approved REMS, what identifiers to use on REMS documents and how to communicate with FDA about a REMS.  
  • Melons, Tomatoes, and Leafy Greens, January 4, 2010, Closing Date -- FDA has extended its original comment deadline of November 2, 2009, and is seeking comments on its draft Guides to Minimize Microbial Food Safety Hazards of Melons, Tomatoes, and Leafy Greens.  
  • New Animal Drugs, January 6, 2010, Closing Date -- FDA is seeking comments on its proposed rule amending its new animal drug regulations to provide sponsors with flexibility in the format and content of their submissions in recognition of the diversity of products and development programs which a standardized application format may not adequately address. This proposed rule was also the subject of a direct final rule that will become effective on March 8, 2010. Thecomment deadline for the direct final rule also is January 6, 2010.  
  • Mammography Quality Standards, January 7, 2010, Closing Date -- FDA is seeking comments on its draft guidance for industry entitled "The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13," which is intended to provide guidance to mammography facilities and their personnel.  
  • Electroconvulsive Therapy Devices, January 8, 2010, Closing Date -- FDA has opened a public docket to seek comments regarding the current classification process related to electroconvulsive therapy devices (ECT). FDA is considering whether to issue a proposed rule, subject to notice and comment rulemaking, requiring that these devices remain in Class III, followed by the issuance of a regulation requiring submission of a premarket application or product development protocol, or to revise the classification of the devices into Class II, requiring the designation of special controls, or into Class I, requiring only general controls.  
  • Food Containers, January 19, 2010, Closing Date - The U.S. Department of Agriculture -- Agricultural Marketing Service (AMS) is seeking comments on its proposed rule amending its U.S. Standards for the Condition of Food Containers to reflect current industry practices.
  • Computer-Assisted Detection Devices for Radiology, January 19, 2010, Closing Date -- FDA is seeking comments on its draft guidance entitled "Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data-Premarket Notification [510(k)] Submissions," which provides recommendations on how to design and conduct clinical performance studies for CADe devices applied to radiology images and radiology device data.  
  • Post-marketing Safety Reporting for Combination Products, January 29, 2010, Closing Date -- FDA has issued an extension and is seeking comments on its proposed rule to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. The proposed rule is intended to clarify the reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product.