Suicidality, November 8, 2010, Closing Date - FDA is seeking comments on draft guidance entitled "Suicidality: Prospective Assessment of Occurrence in Clinical Trials." The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products. Specifically, this guidance addresses FDA's current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug trials and the general principles for how best to accomplish this assessment during drug development.
Dairy Imports, November 12, 2010, Closing Date - USDA is soliciting comments on a proposed rule that would suspend the historical license reduction provisions of the Dairy Import Licensing Program, 7 CFR part 6, for a period of five years. According to USDA, this temporary suspension is intended to improve program administration and reflect ongoing changes in the markets for cheese and other dairy products subject to import licensing requirements.
LASIK Devices, November 15, 2010, Closing Date - FDA has reopened the comment period to receive information and comments on the post market experience associated with the use of laser-assisted in situ keratomileusis (LASIK) devices, as well as information regarding potential barriers that may exist in providing the agency with feedback regarding LASIK procedures.
Acute Bacterial Skin Drugs, November 26, 2010, Closing Date - FDA is solicitingcomments on a draft guidance entitled "Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment." The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo and minor cutaneous abscesses. FDA's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of the changes in the definitions of ABSSSI and the recommendations for clinical drug development.
FTC "Green Guides," December 10, 2010, Closing Date - FTC is seeking comments on proposed revisions to guidelines that seek to help marketers avoid making misleading environmental claims. The proposed revisions include changes designed to strengthen the FTC's guidance on marketing claims already addressed in the current version, such as what qualifies as "recyclable" or "ozone friendly," as well as provide guidance on marketing claims, like "made with renewable materials," that were not commonly used when the Guides were last reviewed. In developing this guidance, FTC hopes to receive comments on all aspects of the proposal. For general information on the proposed revisions, visit http://www.ftc.gov/green.
Early Clinical Trials with Live Biotherapeutics, December 13, 2010, Closing Date - FDA is soliciting comments on a draft guidance entitled "Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information," dated September 2010. The draft guidance provides investigational new drug application (IND) sponsors with recommendations on the submission of INDs for early clinical trials with live biotherapeutic products (LBPs).
FSIS Inspections and Video Monitoring, December 14, 2010, Closing Date - The Food Safety and Inspection Service (FSIS) is soliciting comments on a draft compliance guide on the use of video or other electronic monitoring or recording equipment in federally inspected establishments. This compliance guide provides information to industry to help it maintain compliance with federal regulations, including humane treatment of livestock and the use of good commercial practices in poultry. The intention of the draft guide is to advise establishments that video or other electronic monitoring or recording equipment can be used in federally inspected establishments.
FDA/CMS Parallel Review of Medical Products, December 16, 2010, Closing Date - FDA and the Centers for Medicare and Medicaid Services (CMS) are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. These agencies believe the public interest will be served by reducing the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are establishing a docket to receive information and comment from the public on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. The agencies are also announcing their intent to create a pilot program for parallel review of medical devices. The pilot program will begin after both agencies have reviewed the public comments on this notice.
Acidified Foods, December 27, 2010, Closing Date - FDA is soliciting comments on a draft guidance entitled "Guidance for Industry: Acidified Foods." The draft guidance, when finalized, will complement FDA's regulations regarding acidified foods, including regulations for specific current good manufacturing practice (CGMP), establishment registration and process filing. The draft guidance is intended to assist commercial food processors in determining whether their food products are subject to these regulations. The draft guidance also is intended to assist processors of acidified foods in ensuring safe manufacturing, processing, and packing processes and in employing appropriate quality control procedures. Under the draft guidance, processors of non-acidified foods (e.g., some acid foods or fermented foods) who are not subject to the acidified food regulations may choose to voluntarily register and file scheduled processes with us using existing forms (Forms FDA 2541 and 2541a). If such processors voluntarily submit this information, FDA plans to make the results of any FDA evaluation of the information available to our investigators-e.g., during inspections of food facilities and during evaluations of foods offered for import.
Bioavailability/Bioequivalence Studies, December 28, 2010, Closing Date - FDA is soliciting comments on a draft guidance for industry and investigators entitled "Safety Reporting Requirements for INDs and BA/BE Studies." This draft guidance is intended to help sponsors and investigators comply with the new requirements in the final rule entitled "Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans."
Approval Pathway for Biosimilars, December 31, 2010, Closing Date - FDA is soliciting comments in connection with its two-day November public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BCPI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" (biosimilar) to, or "interchangeable" with, an FDA-licensed biological product. FDA seeks comments on specific issues outlined in its notice.
Research Without an IND, January 12, 2011, Closing Date - FDA is soliciting comments on draft guidance for industry entitled "Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND." This draft guidance is intended to assist clinical investigators, sponsors and sponsor-investigators in determining whether planned human research studies must be conducted under an IND. The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required and discusses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND requirements.