Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
Requests that the FDA require revisions to the labeling for all over-the-counter acetaminophen-containing drug products marketed under the Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use monograph (OTC Monograph M013): (i) a revision to the “Warnings” subsection, currently found at M013.50(c)(1)(iii) in the Labeling section.
1 awaiting analysis
Requests that FDA, under FDCA §505G(b) (OTC monograph administrative order process), amend OTC Monograph M013 to update Drug Facts labeling for all over-the-counter acetaminophen-containing products. In the alternative, Petitioner asks FDA to initiate such an order on its own
Rear Designated Seating Position Alert
Knockout Mosquito Systems LLC - Exemption/Rulemaking
Request for Comments on the Science and Technology Report; Establishment of Docket; Request for Comments
Providing Comments on CDER Level 2 Guidances
Endangered and Threatened Wildlife and Plants; 90-Day Finding for Three Petitions To List the Yellowstone Bison
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability
Requests that the FDA Admit "Waste Parity" Status: Formally acknowledge that the active estrogenic metabolites used in approved conjugated equine estrogen (CEE) pharmaceuticals (such as Premarin) are molecularly identical to the raw equine metabolites the Agency classifies as prohibited "filth" under Section 402(a)(3) of the FD&C Act
Requests that the FDA evaluate and assume jurisdiction over GonaCon-Equine and ZonaStat-H as New Animal Drugs.
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.
Request that the FDA publicly release documentation sufficient to establish that the aluminum content in Adacel, Boostrix, Engerix-B, Havrix, Infanrix, Infanrix hexa, Kinrix, Pediarix, Pedvax-HIB, Pentacel, Prevnar-13, Synflorix, and Vaqtais is consistent with amount provided in its labeling and pause distribution of each Subject Vaccine