Clinical Research Solutions
FDA revises 2013 guidance for Non-Penicillin Beta-Lactam Drugs
Draft Guidance June 2022 FDA is announcing the availability of a draft guidance titled, "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination." This guidance revises...
Clinical Research Solutions
Maximising on Scientific Advice Procedures in Europe
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
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June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...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,...
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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Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics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...
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Q9(R1) Quality Risk Management
Guidance Document June 2022 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any...
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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...
Clinical Research Solutions
FDA publishes MAPP 5223.6, Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA
Today, FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA (5223.6).”...
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Compounded drug search added to FDA’s NDC directory webpage
FDA recently added a search function to the National Drug Code (NDC) Directory webpage for human drugs compounded by outsourcing facilities that assign NDC numbers to their products. This update was...
Clinical Research Solutions
Electromagnetic Compatibility (EMC) of Medical Devices
Guidance Document June 2022 This guidance document provides the FDA’s recommendations on testing to assess the electromagnetic compatibility of medical devices and information to include in the...