Dockets

Recently active federal rulemakings, soonest-closing first.

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Health Claim Petition for Soluble Fiber from OatrimFDANonrulemaking
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Health Claim Notification for Foods Containing Choline BasedFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light Show ProjectorFDANonrulemaking
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Projector for a Laser Light ShowFDANonrulemaking
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Q-Beam Series for a Laser Light Show & ProjectorsFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Slick Productions Laser Light Show with Eclipse Technologies Lasergraphix Lgx-1000 Ar ProjectorFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Variance for Laser Light ShowFDANonrulemaking
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Laser Light Show ProjectorFDANonrulemaking
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Laser Light Show Mobolazer: ML8-20G, ML8-50RG, ML10-250FDANonrulemaking
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Nonclinical Studies for Development of Pharmaceutical ExcipiFDANonrulemaking
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Information for the use of Human Blood & Blood ComponentsFDANonrulemaking
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Part11, Electronic records, electronic signatures scopeFDANonrulemaking
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Draft Guidance: Sterile Drug Products Produced by Aseptic ProcessingFDANonrulemaking
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Current Good Manufacturing Practices for Medical GasesFDANonrulemaking
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Safe Use of Conjugated Linoleic Acid in Animal FeedFDANonrulemaking
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ANDA Suitability for Epirubicin Hydrochloride InjectionFDANonrulemaking
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Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)FDANonrulemaking
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Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized StandardsFDANonrulemaking
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Labeling Claims Using Net Effective Carbohydrates and Similar TermsFDANonrulemaking
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Modification of 21 CFR Pt. 101.93 to Include Structure/Function ClaIms with Disclaimers that Eliminate Perceived Disease Connotations.FDANonrulemaking
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request the Commissioner of Food and Drugs to amend 21 CFR, Part 5.10) to request the Commissioner of Food and Drugs to amend 21 CFR, Part 101,subpart C: specific nutrition labeling requirements and guidelines, specifically nutrition labeling of dietary supplements 101.36(d)(1), to require the source of the dietary ingredient lycopene to be indentified as from tomato,fungus, or syntheticFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Guidance for industry on Pediatric Drug Development Under the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children ActFDANonrulemaking
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Update on Leukocyte Reduction of Blood and Blood Components; Public WorkshopFDANonrulemaking
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To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operationsFDANonrulemaking
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Amend the Regulations Governing the Labeling of Milk Products that Are Set Out In Part 131 of Title 21 of the Code of Federal Regulations-CLOSEDFDANonrulemaking
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Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical DevicesFDANonrulemaking
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Petition for Review of Codex Standard for Honey Under 21 CFR 130.6 - OPENFDANonrulemaking
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Ban Marketing of Estratest, Estratest H.S. and Syntest D.S. and Syntest H.S. associated with MenopauseFDANonrulemaking
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Cheeses & Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Reopening of the Comment PeriodFDARulemaking
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DSM Nutritional Products, Inc.; Filing of Color Additive PetitionFDANonrulemaking
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Industry Describing Product-Specific Bioequivalence RecommendationsFDANonrulemaking
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Dean Foods Company; Filing of Food Additive Petition (FAP 7A4769)FDANonrulemaking
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General Mills, Inc.; Filing of Food Additive Petition (FAP 7M4770)FDANonrulemaking
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Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical DevicesFDANonrulemaking
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Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical AmendmentFDARulemaking
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Designating Additions to the Current List of Tropical Diseases in Section 1102 of the Food and Drug Administration Amendments ActFDANonrulemaking
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Cheeses & Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Extension of the Comment PeriodFDARulemaking
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Determine That an Abbreviated New Drug Application is Suitable for a Non-Aerosol Oral Spray Anesthetic Delivering 10 MG Lidocaine Per Metered Dose.FDANonrulemaking
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To Determine Whether Didrex 25 mg (Benzphetmine Hydrochloride) Tablets (NDA 12-427) by Pharmacia & Upjohn Company, Has Been Voluntarily Withdrawn or Withheld from Sale for Safety or Efficacy ReasonsFDANonrulemaking
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Request to Submit an Abbreviated New Drug Application for Tretinoin Cream in Strength of 0.1%.FDANonrulemaking
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Determine Whether a 1 gm/20 mL (50 mg/mL) Presentation of Fluorouracil Injection, USP Can Be Added to Ebewe Pharma's Existing ANDA 40-772 Fluorouracil Injection USP 50 mg/mL (500 mg/10mL)FDANonrulemaking
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Cough/Cold Drug Products Containing TannatesFDANonrulemaking
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Require that all Television Advertisements for Prescription Drugs & Over the Counter Drugs include a Toll-Free Number & a Website Address for the Public to Report Side Effects to the AgencyFDANonrulemaking
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Initiate Rulemaking Addressing Authoritative Statement Nutrient Content ClaimsFDANonrulemaking
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Draft Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic ActFDANonrulemaking
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