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Today, the U.S. Food and Drug Administration issued the revised draft guidance Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers.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FDA Issues Revised Draft Guidance on Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers Read More »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.

The guidance for industry entitled “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” provides recommendations to applicants planning abbreviated new drug application (ANDA) submissions on how to meet the bioequivalence (BE) requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. The guidance for industry entitled …

FDA publishes two final guidances for industry: “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” and “Statistical Approaches to Establishing Bioequivalence” Read More »

On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).