FDA reopened the comment period for an additional 30 days for the docket to solicit public comment on the multiple guidances for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms
The Food and Drug Administration (FDA) has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using alli …
This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov. Specialists from the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) will address frequently asked questions regarding regulatory obligations and the ClinicalTrials.gov Protocol Registration and Results System (PRS).
Today, the U.S. Food and Drug Administration is extending the comment period by 30 days for the Request for Information on Drug Repurposing for Unmet Medical Needs. On May 12, 2026, the FDA issued a Request for Information to solicit input and comments on FDA’s efforts with respect to drug repurposing to address unmet medical needs.
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Today, the U.S. Food and Drug Administration issued the revised draft guidance Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers.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’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 …
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 »
