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Start Over Collections Health Policy and Services Research ✖ Subjects United States ✖ Publication Year 2022 ✖

381. Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):: Antineoplastic Agents
Biological Products
Clinical Trial Protocols as Topic
Clinical Trials as Topic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

382. Providing submissions in electronic format: postmarketing safety reports

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Drug Approval
Electronic Mail
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

383. Drug products, including biological products, that contain nanomaterials

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Biological Products -- standards
Drug Approval
Drug Development
Nanostructures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

384. Providing regulatory submissions in electronic and non-electronic format: promotional labeling and advertising materials for human prescription drugs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Advertising -- legislation & jurisprudence
Advertising -- standards
Drug Approval
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

385. Bioavailability studies submitted in NDAs or INDs: general considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Biological Availability
Clinical Trials as Topic
Drug Approval
Drug Evaluation
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

386. Reconditioning of fish and fishery products by segregation

Publication:: College Park, MD : Center for Food Safety and Applied Nutrition, April 2022
Subject(s):: Fish Products -- standards
Fisheries -- standards
Food Contamination -- prevention & control
Food Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

387. Facet screw systems: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, April 13, 2022
Subject(s):: Bone Screws -- standards
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

388. Denture base resins: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration Staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, April 13, 2022
Subject(s):: Denture Bases -- standards
Equipment Safety
Resins, Synthetic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

389. Surgical sutures: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, April 11, 2022
Subject(s):: Device Approval
Sutures -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

390. Orthopedic fracture fixation plates: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, April 11, 2022
Subject(s):: Device Approval
Equipment Safety
Fracture Fixation
Orthopedic Fixation Devices -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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