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Five EU regulatory authorities have published a joint plan to support the implementation of the One Health agenda in the EU, a plan help prevent and respond to health threats. Read More
HHS leadership and coordination challenges with handling public health emergencies, particularly its management of the Strategic National Stockpile (SNS), was scrutinized in a Government Accountability Office (GAO) report resulting in recommendations for improvement. Read More
NDAs, ANDAs and BLAs need to incorporate risk evaluation and mitigation strategies (REMS) with clear goals, objectives, and strategies that align with the intended outcomes not only for the design of the REMS but also for future modification, a new FDA draft guidance says. Read More
The overall quality of data and risk of potential bias in them should be top of the mind for European sponsors who want to employ real-word data (RWD) in non-interventional studies (NIS), according to a reflection paper released by the European Medicines Agency. Read More
The FDA’s CDER has released 2023 Annual Reports for its Offices of New Drugs (OND) and Translational Sciences (OTS), highlighting activities that span dozens of drug approvals and guidances from developing AI-enabled software prototypes to identify adverse drug events. Read More
Using Sarepta’s treatment for Duchenne muscular dystrophy (DMD) as an example, a researcher from the Institute for Clinical Review (ICER) said in a recent article that the FDA should be cautious in granting full approval to drugs that fail confirmatory tests. Read More
“Skinny labeling” on 15 generic drugs saved Medicare an estimated $14.6 billion from 2015-2021, but patent lawsuits may threaten the practice, according to an analysis published in the Annals of Internal Medicine. Read More
Shouldering the cost of FY25 federal employee pay increases may cause the FDA’s Office of Regulatory Affairs (ORA) to reduce the number of inspections it can conduct, said the office’s Associate Commissioner for Regulatory Affairs Michael Rogers during an Alliance for a Stronger FDA webinar Wednesday. Read More