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EMA’s Emergency Task Force (ETF) is engaging with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs), leveraging expertise from the WHO-AFRO African Vaccines Regulatory Forum (AVAREF), to discuss possible clinical trial designs and medical countermeasures to be investigated in the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC) and Uganda, caused …

EMA, AMA and African regulatory authorities join forces on Ebola outbreak response Read More »

On May 13, 2026, the FDA Center for Drug Evaluation and Research, in partnership with the CDER Quantitative Medicine Center of Excellence, announced a request for information regarding an initiative to advance biomarker validation through data compilation from multiple sources. Specifically, a pilot project was launched that focuses on aggregating data for biomarkers of drug-induced …

FDA Announces Request for Information Regarding Biomarkers of Drug-Induced Kidney Injury Read More »

Today, the U.S. Food and Drug Administration issued the revised draft guidance Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers.  This guidance answers common questions concerning firms’ communication of health care economic information (HCEI) on prescription drugs and devices to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis.  It addresses the communication of HCEI to payors regarding approved/cleared medical products, as well …

FDA Issues Revised Draft Guidance on Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers Read More »

FDA’s Center for Drug Evaluation and Research (CDER) has accepted the first Letter of Intent (LOI) for an in silico drug development tool (DDT) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT Qualification Program. The DDT is an artificial intelligence (AI)-Driven Digital Liver Model for Prediction of Drug-Induced Liver Injury (DILI).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “M15 General Principles for Model-Informed Drug Development.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides general recommendations for the …

FDA Announces the Availability of the Final Guidance “M15 General Principles for Model-Informed Drug Development” Read More »

EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant XFG for the 2026/2027 vaccination campaign. XFG is part of the JN.1 family of Omicron subvariants. Its circulation has increased worldwide since June 2025, peaking at 74% of infections genetically sequenced globally in October 2025, and it still remains prevalent among …

ETF recommends updating COVID-19 vaccines to target XFG variant Read More »

The U.S. Food and Drug Administration (FDA) published a final guidance for industry, “Pulmonary Tuberculosis:  Developing Drugs for Treatment,” last month. The guidance aims to assist sponsors in the clinical development of investigational drugs to treat pulmonary tuberculosis (TB), an airborne bacterial infection caused by Mycobacterium tuberculosis (M. tuberculosis) that primarily attacks the lungs.