Clinical Research Solutions
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues
Guidance Document Center for Drug Evaluation and Research This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program to...
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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...
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FDA Draft Guidance: Risk Management Plans to Mitigate the Potential for Drug Shortages
Industry Draft Guidance Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients.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...
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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...
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FDA Releases Draft Guidance for Industry on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
The FDA’s Office of Clinical Pharmacology within the Office of Translational Sciences released a new draft guidance document that, for the first time, clearly addresses the FDA’s recommendations and...
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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...
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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On May 5, 2022, the FDA announced the availability of a draft guidance for industry entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies. This draft guidance...
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FDA announces draft guidance on Benefit-Risk Considerations for Product Quality Assessments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...
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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...
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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...