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The FDA issued two draft guidances aimed at implementing the Drug Supply Chain Security Act’s provisions for an electronic track-and-trace system for certain prescription drugs extending throughout the supply chain — one recommending data and documentation practices and another defining terms such as “suspect products” and “illegitimate products.” Read More
The amendments include a recommendation that sponsors document their rationale for choosing on-site or centralized monitoring or a combination of the two. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design and analysis of safety studies and the potential use of biomarkers in various stages of medicinal development. Read More
The FDA released guidance on the International Council for Harmonization’s good clinical practice guidelines and its addendum on advances in clinical trial design. Read More
In its first ever annual report, the Office of Pharmaceutical Quality highlighted its main accomplishments in 2017 and noted it faced major challenges with more than 100 of its 1,300 officers deployed for inspections in the aftermaths of Hurricanes Harvey, Irma and Maria. Read More
Commenting on FDA’s planned patient-focused drug development guidance, industry stakeholders said the agency needs to clarify how it will incorporate patient experience data into specific stages of development. Read More
Additionally, 21 member states impose penalties for falsification across the manufacturing supply chain, including manufacturing, distribution, brokering, import, export and sale at a distance. Read More
Researchers at the FDA and the Centers for Medicare and Medicaid Services are considering whether a cell-based influenza vaccine might be more effective than the egg-based vaccine that did not prove very effective against this year’s H3N2 flu strain, according to Commissioner Scott Gottlieb. Read More
The Justice Department is creating a task force to combat the opioid crisis and plans to file a Statement of Interest in multidistrict litigation against distributors and manufacturers of opioids, according to Attorney General Jeff Sessions. Read More