Clinical Research Solutions
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...
Clinical Research Solutions
Draft Guidance June 24, 2022 The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation. This draft guidance...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
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...
Clinical Research Solutions
Draft Guidance June 2022 FDA is announcing the availability of a draft guidance titled, "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination."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
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...
Clinical Research Solutions
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...
Clinical Research Solutions
June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...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
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...
Clinical Research Solutions
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
Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics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...