January 25, 2012
The Food and Drug Administration (FDA) has announced the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations.

January 25, 2012
The Food and Drug Administration (FDA) has announced the availability of a guidance document entitled, “Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling”.

January 19, 2012
The Guidance for Industry entitled, “Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage’, is available.

January 4, 2012
The draft guidance, “E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility”, is available.

December 30, 2011
The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices”.

December 30, 2011
The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled, “Use of Histology in Biomarker Qualification Studies”.

December 30, 2011
The FDA has announced the availability of a document entitled, “Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products”.