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Requesting that the FDA declare that Potassium Chloride Extended release for Liquid Suspension, 8 mEq and 10 mEq, are suitable for submission as an ANDAFDANonrulemaking
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Requests that the FDA Require Adequate Cardiovascular Safety and All- Cause Mortality Data Be Submitted to FDA for Review Before Approving Roxadustat (FG-4592) for the Treatment of Anemia in Patients with Chronic Kidney Disease (CKD), and Require a Boxed WarningFDANonrulemaking
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Request that the FDA take the following three actions described below: 1. Refuse to approve the Glenmark generic topical clobetasol propionate product submitted under ANDA 214191, and any similarly formulated generic products, because there is a reasonable basis to conclude that Glenmark made formulation changes, including significant changes to the vehicle, that likely increase absorptionFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Gardenia Blue Interest Group; Filing of Color Additive PetitionFDANonrulemaking
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Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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CVM GFI #91 (VICH GL8) Stability Testing for Medicated PremixesFDANonrulemaking
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CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef CattleFDANonrulemaking
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Content of Premarket Submissions for Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Agency Information Collection Activities; Proposed Collection; Comment RequestFDANonrulemaking
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Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet]; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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General Mills, Inc.; Filing of Food Additive PetitionFDANonrulemaking
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Modified Risk Tobacco Product Application: Application for the IQOS 3 System Holder and Charger Submitted by Phillip Morris Products S.AFDANonrulemaking
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Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed RuleFDARulemaking
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Revising the National Drug Code Format and Drug Label Barcode RequirementsFDARulemaking
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Requests that the FDA remove all octocrylene products from the marketplace based on human health risks associated with the unavoidable presences of the carcinogenic benzophenone.FDANonrulemaking
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Requests that the FDA take the actions set forth below in petition with respect to abbreviated new drug applications (ANDAs) and section 505(b)(2) applications that reference or rely upon OptiNose’s XHANCE® (fluticasone propionate) nasal spray.FDANonrulemaking
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Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an Abbreviated New Drug ApplicationFDANonrulemaking
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Request that the FDA declare that Diltiazem Hydrochloride ExtendedRelease Capsules, 60 mg, is suitable for submission as an ANDFDANonrulemaking
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Requests that the FDA not approve ANADA #200-710 submitted by Dechra Veterinary roducts, for Emavert, referencing Zoetis' Cerenia Injectable Solution NADA 141-263FDANonrulemaking
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75‐Day Premarket Notification for New Dietary Ingredients_2021FDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Variance RequestFDANonrulemaking
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Variance RequestFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Light Show ShowFDANonrulemaking
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Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment RequestFDANonrulemaking
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Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Otic, and Ophthalmic Use; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; AvailabilityFDARulemaking
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Recommendations for Determining Risk of Hepatitis B Virus (HBV) Infection for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for IndustryFDANonrulemaking
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Recommendations for Determining Risk of Hepatitis C Virus (HCV) Infection for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for IndustryFDANonrulemaking
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Recommendations for Determining Risk of Human Immunodeficiency Virus (HIV) Infection for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for IndustryFDANonrulemaking
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Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry; AvailabilityFDARulemaking
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Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment RequestFDANonrulemaking
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Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; AvailabilityFDANonrulemaking
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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General and Species-Specific Recommendations; Guidances for IndustryFDANonrulemaking
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Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development; International Council for Harmonisation; Draft Guidances for Industry; AvailabilityFDANonrulemaking
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