Clinical Research Solutions
How to Interpret FDA’s Final Guidance - “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”
On June 23, 2022, The FDA issued the final version of its Guidance for Industry titled “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”. The most...
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FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
Draft Guidance June 24, 2022 The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation. This draft guidance...
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EMA Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus
8 June 2022 EMA/175959/2021 Rev.2 Human Medicines Division Regulatory and procedural requirements Introduction In order to ensure the continued effectiveness of authorised COVID-19 vaccines, it may...
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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Draft Guidance June 2022 FDA is announcing the availability of a draft guidance titled, "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination."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...
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EMA Checklist for annual updates for parallel distribution - Draft Guidance
22/06/2022 EMA/405782/2020 Rev. 3 Human Medicines Division The European Medicines Agency (hereinafter 'the Agency') asks its applicants to use this checklist in advance of submission of an annual...
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Advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans - in relation to implementing measures under Article 37(5) of Regulation
Regulatory and Procedural Guideline May 2022 EMA/CVMP/678496/2021-rev Introduction “According to Article 37(5) of Regulation (EU) 2019/6 (‘the Regulation’), the European Commission shall adopt...
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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June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...
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Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)
JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...
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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...