Clinical Research Solutions
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Draft Guidance July 2022 This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application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 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
Clinical Pharmacology Considerations for Oligonucleotides
For the first time, the FDA has issued a draft guidance for industry on “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”. Oligonucleotides are short single...
Clinical Research Solutions
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” This...
Clinical Research Solutions
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...
Clinical Research Solutions
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
Draft Guidance June 24, 2022 The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation. This draft guidance...
Clinical Research Solutions
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures
June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...
Clinical Research Solutions
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
Guidance Document Guidance for Industry and Food and Drug Administration Staff JUNE 2022 This guidance document provides FDA's recommendations on the information, technical performance assessment,...
Clinical Research Solutions
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation...
Clinical Research Solutions
Understanding ICH M10 “Bioanalytical Method Validation and Study Sample Analysis”
The final version of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” was adopted on May 24, 2022. This is the harmonized guideline which has been ratified by participating...