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...
Draft Guidance June 2022 FDA is announcing the availability of a draft guidance titled, "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination."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...
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...
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...
June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...
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...
Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics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...
Guidance Document June 2022 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.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...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...