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FDA has published its annual guidance document agenda. The agency is seeking comments on this list of possible topics to be addressed in future guidance documents or in revisions to existing documents. Below are some of the topics the Center for Drug Evaluation and Research is considering for the coming year. The complete list can be found in the Dec. 7 Federal Register notice.
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Advertising
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Amendment of the Brief Summary
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Comparative Claims in Prescription Drug Promotion
(Also see "FDA May Allow "Qualitative" Labels For Data In DTC Ads" - Pink Sheet, 31 Aug, 2010.)
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Direct to Consumer Television Advertisements – Preview Program Under the Food and Drug Administration Amendments Act
(Also see "DDMAC, Soon To Be An Office, Hones In On DTC Advertising" - Pink Sheet, 25 Oct, 2010.).
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Promotion of Prescription Drug Products Using Social Media Tools
(Also see "FDA's Internet Promotion Policy: Christmas Cards In Lieu Of Guidance?" - Pink Sheet, 3 Jan, 2011.)
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Clinical/Medical
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Clinical Development of Drugs for Irritable Bowel Syndrome
(“Salix Rifaximin NDA Plans OK Despite New Guidance,” “Pharmaceutical Approvals Monthly,” Dec. 1, 2009)
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Oncology Endpoints: Non-Small Cell Lung Cancer
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Qualification Process for Drug Development Tools
(Also see "FDA Drug Development Tool Guidance Leaves Door Open For Advisory Committee Reviews" - Pink Sheet, 15 Nov, 2010.)
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Responsible Inclusion of Pregnant Women In Clinical Trials
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Clinical/Statistical
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Adaptive Trial Designs
(Also see "Adaptive Trials Could Have A Steep Regulatory Learning Curve" - Pink Sheet, 8 Mar, 2010.)
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Multiple Endpoints
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Non-Inferiority Trials
(Also see "Non-Inferiority Studies May (Bio)Creep Out Of Limelight After GAO Report" - Pink Sheet, 6 Sep, 2010.)
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Combination products
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Drug Diagnostic Co-Development
(Also see "FDA's Seyfert-Margolis On Companion Diagnostics Guidance" - Pink Sheet, 8 Nov, 2010.)
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Development of Drugs in Combination
(Also see "FDA Issues Co-Development Guidance, But Only For Products Treating "Serious" Diseases" - Pink Sheet, 14 Dec, 2010.)
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Current Good Manufacturing
Practices/Compliance
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Importation of Active Pharmaceutical Ingredients for Use in Human Drugs
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Drug Safety Information
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Best Practices for Conducting Pharmacovigilance Studies Using Electronic Healthcare Data
(Also see "FDA Finds “Comfort Level” With Using Medicare Data For Sentinel Initiative" - Pink Sheet, 11 Oct, 2010.)
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Dear Healthcare Professional Letters
(Also see "FDA Standardizing “Dear Doc” Letters To Fix Problems With Recipients As Much As Senders" - Pink Sheet, 29 Nov, 2010.)
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Good Naming, Labeling, and Packaging Practices to Reduce Medication Errors
(Also see "Dangerous Clutter: FDA Takes On Errors Caused By Drug Labels, Packaging" - Pink Sheet, 5 Jul, 2010.)
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Investigational New Drug Applications
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Adverse Events: Collection and Reporting for Secondary Endpoints
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Determining Whether Human Research Studies Can Be Conducted Without An IND
(Also see "INDs Needed For Some Comparative Effectiveness Research, FDA Suggests" - Pink Sheet, 1 Nov, 2010.)
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IND Safety Reporting
(Also see "FDA IND Safety Reporting Rule: New Types Of Data Must Be Submitted" - Pink Sheet, 4 Oct, 2010.)
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