Dockets

Recently active federal rulemakings, soonest-closing first.

• Filing of Color Additive Petition from Environmental Defense Fund, et al.; Request to Amend the Color Additive Regulations to Remove the Solvents Ethylene Dichloride, Methylene Chloride, and TrichloroethyleneFDANonrulemaking
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• Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; AvailabilityFDANonrulemaking
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• M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Development of Local Anesthetic Drug Products With Prolonged Duration of Effect; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; AvailabilityFDANonrulemaking
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• Registration and Listing of Cosmetic Facilities and Products; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Classification Categories for Certain Supplements Under BsUFA III; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• E6(R3) Guideline for Good Clinical Practice; International Council for Harmonisation; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Patient-Matched Guides to Orthopedic Implants; Draft Guidance for Industry and Food and Drug Administration Staff; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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• QTc Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Priority Zoonotic Animal Drug Designation And Review Process; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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• Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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• Patent Term Extension Application for Impella RP Flex™ with Smart Assist®, Patent No. 9,750,861FDANonrulemaking
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• Patent Term Extension Application for ADBRY® (tralokinumab), Patent No. 7,935,343FDANonrulemaking
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• Patent Term Extension Application for Agili-C, Patent No. 8,808,725FDANonrulemaking
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• Patent Term Extension Application for Agili-C, Patent No. 11,116,873FDANonrulemaking
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• Patent Term Extension Application for Aveir VR Leadless System, Patent No. 8,295,939FDANonrulemaking
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• Patent Term Extension Application for Aveir VR Leadless System, Patent No. 9, 168, 383FDANonrulemaking
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• Patent Term Extension Application for PASCAL Precision Transcatheter Valve Repair System\PASCAL Precision 10,507,102FDANonrulemaking
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• Patent Term Extension Application for BEXACAT\BEXACAT 8987323FDANonrulemaking
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• Patent Term Extension Application for BEXACAT\BEXACAT 8106021FDANonrulemaking
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• Patent Term Extension Application for BRENZAVVY 10981942FDANonrulemaking
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• Patent Term Extension Application for BRENZAVVY 10533032FDANonrulemaking
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• Patent Term Extension Application for BRENZAVVY 8,802,637FDANonrulemaking
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• Patent Term Extension Application for BRENZAVVY 7,838,499FDANonrulemaking
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• Patent Term Extension Application for ROLVEDON\ROLVEDON 11,147,857FDANonrulemaking
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• Patent Term Extension Application for Impella RP Flex with Smart Assist, Patent No. 9,402,942FDANonrulemaking
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• Patent Term Extension Application for Impella RP Flex with Smart Assist, Patent No. 11,007,350FDANonrulemaking
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• Patent Term Extension Application for HEMGENIX (etranacogene dezaparvovec-drlb), Patent No. 9,249,405FDANonrulemaking
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• Patent Term Extension Application for Elahere (mirvetuximab soravtansine-gynx), Patent No. 8,557,966FDANonrulemaking
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• Patent Term Extension Application for Elahere (mirvetuximab soravtansine-gynx), Patent No. 8,613,930FDANonrulemaking
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• Patent Term Extension Application for Elahere (mirvetuximab soravtansine-gynx), Patent No. 8,624,003FDANonrulemaking
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• Patent Term Extension Application for Elahere (mirvetuximab soravtansine-gynx), Patent No. 8,709,432FDANonrulemaking
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• Patent Term Extension Application for Elahere (mirvetuximab soravtansine-gynx), Patent No. 9,598,490FDANonrulemaking
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• Patent Term Extension Application for LEQEMBI (lecanemab-irmb), Patent No. 8,025,878FDANonrulemaking
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• Patent Term Extension Application for BRIUMVI (ublituximab-xiiy), Patent No. 9,234,045FDANonrulemaking
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• Patent Term Extension Application for BRIUMVI® (ublituximab-xiiy), Patent No. 9,873,745FDANonrulemaking
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• Patent Term Extension Application for SUNLENCA (lenacapavir), Patent No. 9,951,043FDANonrulemaking
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