Dockets

Recently active federal rulemakings, soonest-closing first.

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Inapplicability of the Dietary Supplement Health & Education ActFDANonrulemaking
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Ephedrine Alkaloids: Reports of Adverse Events; AvailabilityFDANonrulemaking
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Quality/fill Container; Common or Unusual Name RegulationsFDANonrulemaking
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In Vitro Diagnostic Devices; Tier/Triage Management Initiative; Notice of Public Workshop & Public CommentsFDANonrulemaking
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Protection of Human Subjects; Informed ConsentFDANonrulemaking
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Opportunity for Hearing on Proposal to Withdraw 2 ANDA's & 1 AADAFDANonrulemaking
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Products Comprised of Living Autologous CellsFDANonrulemaking
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PTCs for Developing Medical Imaging AgentsFDANonrulemaking
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Topical Antimicrobial Drug Products for OTC Human UseFDANonrulemaking
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Regulations Restricting the Sale & Distribution of Cigarettes & Smokeless Tobacco to Protect Children & AdolescentsFDARulemaking
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PMA or Product Development Protocol for Dry Heat SterilizerFDANonrulemaking
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Reclassify Rigid Gas Permeable Contact Lens SolutionFDANonrulemaking
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Carcinogenicity Testing of Compounds Used in Food-Producing AnimalsFDANonrulemaking
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Fredrick Jay Shainfeld; Debarment OrderFDANonrulemaking
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Jurisdiction Nicotine Cigarette/Smokeless Tobacco ProductsFDANonrulemaking
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Statement of Identity, Nutrition Labeling & IngredientsFDANonrulemaking
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Revise "Approved Drug Products" (Known as "Orange Book")FDANonrulemaking
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Request to Amend Regulation of the FDAFDANonrulemaking
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ANDA Suitability for 2.5mg Hydrocodone Bitrate & 5mg PhenylephrineFDANonrulemaking
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ANDA Suitability for Carbidopa/Levodopa Powder for Reconstitution to an Oral LiquidFDANonrulemaking
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ANDA for Butalbital, Acetaminophen, Caffeine and HydrocodoneFDANonrulemaking
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ANDA Suitability for Metronidazole in Topical Lotion 0.75% (7.5mg/g)FDANonrulemaking
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Amend Monograph on Antiemetic Drug Prods for OTC Human UseFDANonrulemaking
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Implied Nutrient Content Claim 'Healthy' & Health ClaimsFDANonrulemaking
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Oat Products & Coronary Heart DiseaseFDANonrulemaking
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ANDA for Nifedipine Extended-Release CapsulesFDANonrulemaking
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Add Terminal Dry-Heat Inactivation of Plasma-Derived Factor8FDANonrulemaking
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Refuse to Approve Any NDA for RU 486 Used as AbortifacientFDANonrulemaking
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Albuterol Inhalation Aerosols (Metered Dose Inhalers)FDANonrulemaking
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ANDA Suitability for Captopril Concentrated Oral SolutionFDANonrulemaking
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Use URAA to Determine Approval eff date of ANDA'sFDANonrulemaking
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Exempt Medical Gases from the Requirements of 21 CFR 205FDANonrulemaking
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Regulate Caffeine Beverages as Drugs and/or DevicesFDANonrulemaking
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Prescription Drug AdvertisementsFDANonrulemaking
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Modify Advice Bioequivalence of Generic Ammonium LactateFDANonrulemaking
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Permit the Removal of Fat from Standardized FoodsFDANonrulemaking
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ANDA Suit for Hydrocortisone Butyrate Topical Creamy LotionFDANonrulemaking
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Ban the Use of Lindane as a Treatment for Lice & ScabiesFDANonrulemaking
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Refrain from Approval ANDA for Aluminum Hydroxide Dried GelFDANonrulemaking
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ANDA Suitability for Acyclovir Sodium Ready-to Use InfusionFDANonrulemaking
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Enforce SMDA & Existing Regulations-Re: Manufacturing of Dental LubricantsFDANonrulemaking
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ANDA Suitability Cholestyramine Chewable TabletFDANonrulemaking
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ANDA Suitability for Meperidine Hydrochloride InjectionFDANonrulemaking
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ANDA Suitability for Hydrocodone Bitartrate and Acetaminophen (5mg/325mg) Capsule FormFDANonrulemaking
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Approve Therapeutic Equivalent Transdermal Nitro PatchesFDANonrulemaking
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Permit Term Polyols in Lieu of Sugar Alcohols on Food LabelFDANonrulemaking
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ANDA Suit for Hydromorphone Hcl Intravenous Injection 0.2 mg per mL in a 50mL Prefilled SyringeFDANonrulemaking
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Objectives Re: Enforcement of Medical Device RegulationsFDANonrulemaking
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Cease Regs on Prescription Drug Advertisements to ConsumersFDANonrulemaking
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Waiver for Feminine Gold Eternal Topical Analgesic LotionFDANonrulemaking
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