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521. Exemption and exclusion from certain requirements of the Drug Supply Chain Security Act for the distribution of FDA-approved naloxone products during the opioid public health emergency: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Government Regulation
Legislation, Drug
Naloxone -- supply & distribution
Opioid Epidemic -- prevention & control
United States
United States. Food and Drug Administration

522. Competitive generic therapies: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
United States. Food and Drug Administration

523. Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Group Processes
United States
United States. Food and Drug Administration

524. Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration

525. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Subject(s):: Device Approval -- legislation & jurisprudence
Government Regulation
Product Surveillance, Postmarketing
United States
United States. Food and Drug Administration

526. Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Subject(s):: Clinical Studies as Topic
Device Approval
Government Regulation
United States
United States. Food and Drug Administration

527. Infant formula enforcement discretion policy: guidance for industry

Publication:: College Park, MD : Center for Food Safety and Applied Nutrition, May 2022
Subject(s):: Food Supply -- legislation & jurisprudence
Government Regulation
Infant Formula -- legislation & jurisprudence
United States
United States. Food and Drug Administration

528. Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Capsules -- standards
Drugs, Generic -- standards
Government Regulation
Tablets -- standards
United States
United States. Food and Drug Administration

529. CBO’s Medicaid baseline forecast

Author(s):: Stewart, Robert, (Of Congressional Budget Office), author
Publication:: [Washington, D.C.] : Congressional Budget Office, November 15, 2022
Subject(s):: Medicaid -- economics
Medicaid -- statistics & numerical data
Medicaid -- trends
United States

530. Policy approaches to reduce what commercial health insurers pay for hospitals’ and physicians’ services

Author(s):: Cohen, Michael, (Of Congressional Budget Office), author
Pelech, Daria, author
Stockley, Karen, author
Publication:: [Washington, D.C.] : Congressional Budget Office, November 14, 2022
Subject(s):: Cost Control
Health Care Costs -- statistics & numerical data
Health Policy -- economics
Insurance, Health -- economics
United States

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