Clinical Research Solutions
FDA announces guidance for industry titled Changes to Disposable Manufacturing Materials: Questions and Answers
Today, FDA is announcing the availability of a level 2 guidance for industry titled, Changes to Disposable Manufacturing Materials: Questions and Answers. FDA receives questions about the limited...
Clinical Research Solutions
FDA announces the availability of a proposed rule: Revising the National Drug Code Format and Drug Label Barcode Requirements
On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), that is intended to...
Clinical Research Solutions
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry
Final Guidance July 2022 This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications...
Clinical Research Solutions
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings
Final Guidance July 2022 This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred...
Clinical Research Solutions
FDA publishes two final guidances for industry: Orange Book Questions and Answers; Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
July 2022 As part of FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug...
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Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”
Draft Guidance July 2022 This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application (NDA) submitted under the...
Clinical Research Solutions
FDA Draft Guidance for Industry, Evaluation of Therapeutic Equivalence
FDA Draft Guidance July, 2022 As part of the FDA’s continued efforts to provide helpful information to regulated industry and the public, the agency has published a draft guidance for industry,...
Clinical Research Solutions
FDA Issues Final Guidance on Instructions for Use Documents
The U.S. Food and Drug Administration has issued a final guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format.” The Instructions...
Clinical Research Solutions
CVM GFI #245 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
July 2022 The purpose of this guidance is to help animal food facilities develop a food safety plan that complies with FDA’s Hazard Analysis and Risk-Based Preventive Controls requirements....
Clinical Research Solutions
FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act
FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act FDA is announcing the availability of two guidances to help trading partners comply with the Drug Supply Chain Security...