Dockets

SkyWest Airlines, Inc. - Notice of Intent to Terminate Scheduled Air Service at Imperial, California

Guidance for Industry: Questions and Answers on HACCP Regulation for Fish and Fishery Products

Request to Promulgate a Series of Regulations to Protect U.S. Consumers From Cesium 134 and Cesium 137 Contamination

Requests that the FDA to issue a regulation, request recalls, revise industry guidance, and take such other actions set forth below.

Request that the FDA take the following three actions: A) Encourage Novo Nordisk to sign over the FDA rights to manufacture detemir (Levemir) insulin to an organization who will ensure that a biosimilar gets made. This organization could be a non-profit, a contract manufacturer, or other pharmaceutical company to be determined. B) Encourage Novo Nordisk to allow Levemir (detemir) to be purchased

Request that the FDA classify and regulate NarxCare, a proprietary risk-scoring algorithm used in Prescription Drug Monitoring Programs (PDMPs), as a Software as a Medical Device (SaMD)

Requests the FDA to take the administrative action to require that the reported malfunction, failure, or patient harm (collectively referred to hereafter as “failure”) in an FDA-regulated medical device, when said failure is directly associated with or temporally immediately following exposure to an MRI scanner, through MedWatch or MDR reporting channels,

Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application; Guidance for Industry

Requests that the FDA codify, regularize, and transparently administer a principle the Agency already recognizes in practice: that the adequacy of an investigation in rare diseases cannot be determined by default assumptions alone. It does not ask FDA to invent a new principle or apply distinct evidentiary thresholds or concessions to rare disease research programs.

Request that the FDA take the administrative action to implement minimum RF safety national requirements for MRI devices to increase end-user understanding of the physical locations of RF risks (to better understand and manage those risks) and / or to eliminate the risk of near-field RF burns for MRI patients

Request that FDA order sponsors of immunotherapies for NSCLC to revise their respective Prescribing Information to reflect that patients with ROS1 and RET rearrangements should use targeted therapies as their first line option, relying on its statutory authority under section 505(o)(4) of the FDC Act.

Requests that the FDA conduct “[a] study to determine the necessity for the development of standards for the use of nonmedical electronic products for commercial and industrial purposes” and provide a report to Congress