Dockets

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

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 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

Requests that the FDA take the following measures to protect the public from mercury exposure and other risks caused by dental amalgam: (1) Ban dental amalgam, (2) Ban the use of dental amalgam at least in high-risk populations, including children, pregnant women, women who are planning to become pregnant, nursing women, people with neurological disease, people with impaired kidney function

Charter Server Complaints

Matthew T. Keefe - Exemption/Rulemaking