January 24, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending its regulations governing the content and format of labeling for human prescription drug products (including biological products that are regulated as drugs). The final rule revises current regulations to require that the labeling of new and recently approved products include highlights of prescribing information and a table of contents. The final rule also reorders certain sections, requires minor content changes, and sets minimum graphical requirements. These revisions will make it easier for health care practitioners to access, read, and use information in prescription drug labeling. The revisions will enhance the safe and effective use of prescription drug products and reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information. For both new and recently approved products and older products, the final rule requires that all FDA-approved patient labeling be reprinted with or accompany the labeling. The final rule also revises current regulations for prescription drug labeling of older products by clarifying certain requirements. These changes will make the labeling for older products more informative for health care practitioners.

The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Labeling for Human Prescription Drug and Biological ProductsImplementing the New Content and Format Requirements'' and ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' These draft guidances are two of a series of guidance documents intended to assist applicants in complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products published elsewhere in this issue of the Federal Register. Elsewhere in this issue of the Federal Register, the agency is announcing the availability of two guidances on the content and format of the ``Clinical Studies'' and ``Adverse Reactions'' sections of labeling.

The FAA is adopting a new airworthiness directive (AD) for certain Turbomeca Arriel 1B, 1D, 1D1, and 1S1 turboshaft engines. This AD requires initial and repetitive position checks of the gas generator 2nd stage turbine blades on all Turbomeca Arriel 1B, 1D, 1D1, and 1S1 turboshaft engines, and initial and repetitive replacements of 2nd stage turbines on 1B, 1D, and 1D1 engines only. This AD results from reports of the release of gas generator 2nd stage turbine blades while in service, with full containment of debris. We are issuing this AD to prevent inflight engine shutdown and subsequent forced autorotation landing or accident.