Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
1 awaiting analysis
Requests that the FDA revise existing regulations and policies to require drug and dietary supplement manufacturers to clearly label whether ingredients used in their products are animal derived or contain animal byproducts.
1,582 awaiting analysis
Request that FDA promulgate rules governing the labeling of animal-derived ingredients. Specifically, petitioners urge the agency to require products that contain animal-derived ingredients to be labeled with a disclaimer on the product’s Principal Display Panel (PDP) that states that the product contains animal-derived ingredients, identifying the species in the statement.
571 awaiting analysis
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
41 awaiting analysis
Requests that the FDA order and/or take an administrative action, as provided in the below proposed order; under the Authority: 5 U.S.C. §551-§558, §701-§706; 15 U.S.C. §1451-§1461; 21 U.S.C. §141-§149, §321-§397, §467f, §679, §821, §1034; 28 U.S.C. §2112; 42 U.S.C. §201, §262, §263b, §264.
29 awaiting analysis
Request that the FDA reconsider the classification of dental amalgam fillings into Class II per the FDA's August 4, 2009, Final Rule
35 awaiting analysis
Requests that the FDA Limit the Exposure of Refined Carbohydrates used in Industrial Processing in order to Prevent Obesity, Diabetes, and Cardiovascular Disease in Children and Adults
484 awaiting analysis
Request that the FDA to revoke all BLA’s for every mRNA COVID-19 vaccine for all demographic groups because manufacturers do not and have never met BLA standards
68 awaiting analysis
Requests that the FDA Open a Docket, Hold a Part 15 Public Hearing Regarding the Off-Label Use of Estrogen in Natal Males for Gender Affirmation, and Consider Regulatory Action Including a Boxed Warning Under 21 C.F.R. § 201.80(e)
57 awaiting analysis
Proposal to Debar Andrew Jonathan Morgan
Request that the FDA amend the prescription status of triptan medications to allow their availability as over-the-counter (OTC) products for the acute treatment of migraine headaches with or without aura in adults who have a previous diagnosis of migrainie
18 awaiting analysis
Requests that the FDA initiate rulemaking to establish a clear, enforceable regulatory definition and substantiation requirements for the animal-raising claim “pasture-raised” as applied to shell eggs from laying hens.
5 awaiting analysis