FDA
North America
May 25, 2022
Importation of Prescription Drugs Final Rule Questions and Answers
Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs from Canada Guidance for Industry Today, FDA issued a Small Entity Compliance Guide to help small businesses comply...
FDA
North America
May 20, 2022
FDA Draft Guidance: Risk Management Plans to Mitigate the Potential for Drug Shortages
Industry Draft Guidance Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s...
FDA
North America
May 19, 2022
FDA Issues Final Guidance on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors
FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The recommendations for prescription drug and...
FDA
North America
May 16, 2022
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision
Guidance for Industry May 2022 Today, FDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this...
FDA
North America
May 10, 2022
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On May 5, 2022, the FDA announced the availability of a draft guidance for industry entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies. This draft guidance...
FDA
North America
May 9, 2022
FDA announces draft guidance on Benefit-Risk Considerations for Product Quality Assessments
Today, FDA announced the availability of a draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments. This guidance describes the benefit-risk principles applied by FDA...
FDA
North America
May 4, 2022
Implementation of ICH E2B(R3)
April 2022 Guidance Document E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide...
FDA
North America
May 4, 2022
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability
May 2022 Guidance Document Download the Final Guidance Document The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of...
FDA
North America
April 29, 2022
Ulcerative Colitis: Developing Drugs for Treatment
Guidance Document April 2022. The purpose of this guidance is to help sponsors in the clinical development of drugs to treat adults with ulcerative colitis (UC). This guidance addresses the Food and...