Dockets

Recently active federal rulemakings, soonest-closing first.

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Revoke Standard of Identity - Various Lower-Fat Milk & Cream ProductsFDANonrulemaking
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ANDA Suit for Diltiazem Hydrochloride InjectionFDANonrulemaking
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ANDA Suitability for Lactulose CrystalsFDANonrulemaking
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Refrain From Granting Market Exclusivity, NicoretteFDANonrulemaking
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Bioequivalance to Transderm-Nitro Nitroglycerin PatchFDANonrulemaking
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Fortification of Foods with Vitamin B6FDANonrulemaking
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Revoke Standard of Identity for Lowfat Milk & Skim MilkFDANonrulemaking
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ANADA for Addition of 1.5% Benzyl Alcohol to Ivomec 1% InjectionFDANonrulemaking
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Revoke Standards of Identity for Evaporated Skimmed milk, Lowfat Dry Milk & Dry CreamFDANonrulemaking
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ANDA for Atracurium Besylate Injection 1.0 mg/mL, 100 mL Flexible ContainerFDANonrulemaking
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Unauthorized Disclosure of FDA Records by FDA PersonnelFDANonrulemaking
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Issue a Guidance/Refuse to Allow an IND for CyclophosphamideFDANonrulemaking
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Metered Dose N-acetylcysteine lysinate for Human Use via Oral InhalationFDANonrulemaking
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Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24FDARulemaking
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Laser Light Show Laser X-3800FDANonrulemaking
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Request for Variance - Mesh-2000 Laser Display DeviceFDANonrulemaking
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Designing Clinical Programs/drugs, devices, treatment of (RA)FDANonrulemaking
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ICH/testing for Carcinogenicity of PharmaceuticalsFDANonrulemaking
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International Conference on Harmonisation; Draft GuidelineFDANonrulemaking
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Impurities in New Drug Products GuidelineFDANonrulemaking
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Certification for Exporting Products from the United StatesFDANonrulemaking
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Safe Use of Aliphatic Polyester-Polyurethane Resin-AcidFDANonrulemaking
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Safe Use of Nylon 6/12 Copolymers for Use as a Non-Food Contact LayerFDANonrulemaking
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Safe Use of Sodium Mono- & Dimethyl Naphthalene SulfonatesFDANonrulemaking
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Safe Use of Dimethyl 1,4-cyclohexanedicarboxylate as a MonomerFDANonrulemaking
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Beta-Cylodextrin as a Flavor Protectant in Human FoodFDANonrulemaking
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Konjac Flour Be Affirmed as GRAS for Use as Food IngredientFDANonrulemaking
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Guideline on Infectious Disease Issues in XenotransplantationFDANonrulemaking
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Home Access Health Corporation; PMA of the Home Access HIV-1 TestFDANonrulemaking
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Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph SystemFDARulemaking
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Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary SupplementsFDANonrulemaking
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Withdrawal of Approval of NADA; I.D. Russell Company LaboratoriesFDANonrulemaking
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Proposal to Withdraw Approval of 41 (NDA's)FDANonrulemaking
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Medical Device Industry InitiativesFDANonrulemaking
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Investigational Device Exemptions; Treatment UseFDANonrulemaking
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Review of Presiding Officer's Opinion-Century Clinic, Inc.FDANonrulemaking
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Sterility Requirements for Inhalation Solution ProductsFDANonrulemaking
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Points to Consider on Plasmid DNA VaccinesFDANonrulemaking
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Drug Export; Abbott MATRIX HCV 2.0FDANonrulemaking
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Establish the in Vivo Bioequivalence Requirement for HetastarchFDANonrulemaking
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ANDA for Selegiline Hydrochloride Tablets 5 MGFDANonrulemaking
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ANDA for Potassium Chloride Extended-Release MicroparticleFDANonrulemaking
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Reclassify Arrhythmia Detector & AlarmFDANonrulemaking
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Rotating Membrane Filtration Blood Cell Separation SystemsFDANonrulemaking
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Amend 'Healthy' Definition-Re: Sodium LevelsFDANonrulemaking
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Beconase AQ Metered Nasal Spray, 0.042mg/INHFDANonrulemaking
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ANDA for a Delayed-Release Cap. of Diclofenac Sodium 50 mgFDANonrulemaking
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ANDA for Potassium Chloride Extended-Release MicroparticlesFDANonrulemaking
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ANDA for Pentoxifylline Extended-release Microparticle PacketsFDANonrulemaking
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Reduce the Precense of Salmonella Enteritidis in Shell EggsFDANonrulemaking
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