FOOD-AND-DRUG-ADMINISTRATION

Medical Devices for Weight Loss: Premarket Considerations Guidance

The Food and Drug Administration (FDA) has published new guidance for industry and FDA staff regarding premarket considerations for medical devices indicated for weight loss. This guidance aims to clarify regulatory pathways and expectations for manufacturers seeking approval for such devices.

FDA - Investigational New Drug Application Requirements Collection

The Food and Drug Administration (FDA) is proposing to collect information related to Investigational New Drug (IND) application requirements. This notice opens a public comment period for stakeholders to provide input on the proposed information collection activities.

FDA Mammography Standards Quality Act Requirements - OMB Review

The Food and Drug Administration (FDA) has submitted a request for Office of Management and Budget (OMB) review regarding information collection activities related to the Mammography Standards Quality Act Requirements. This notice opens a 30-day public comment period.

Animal Food and Egg Regulatory Program Standards Comment Request

The Food and Drug Administration (FDA) is requesting public comments on proposed information collection activities related to Animal Food and Egg Regulatory Program Standards. The comment period is open for 30 days.

FDA Withdraws Proposed Rule on Sunlamp Products

The Food and Drug Administration (FDA) has withdrawn a previously proposed rule concerning the restricted sale, distribution, and use of sunlamp products. This action removes the proposed regulations that were initially published in 2015.