The Federal Register

Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment

Tue, Dec 26 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend its overthecounter (OTC) labeling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include new warnings and other labeling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labeling for all OTC IAAA drug products. The new labeling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labeling changes because it has tentatively concluded they are necessary for these ingredients to be consi

Medical Devices; Exemptions from Premarket Notification; Class II Devices

Tue, Dec 26 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption for cranial orthosis type devices from the premarket notification requirements for certain class II devices. A cranial orthosis device is a device intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry or shape. FDA is publishing this notice in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

Tue, Dec 26 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. This meeting was originally announced in the Federal Register of December 6, 2006 (71 FR page 70780). The amendment is being made to reflect a change in the Agenda portion of the document, specifically to include the name of the sponsors and devices. There are no other changes.