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March 25, 2019

Vol. 18
No. 57


FDA Lays Out Proposed Ground Rules for Natural History Studies

Drug sponsors who want to use natural histories to help develop treatments for rare diseases should draw up well-defined statistical analysis plans and probably even hire statisticians to help develop the histories, the FDA said in new draft guidance issued Friday. Read More

EMA Says Risk of Drug Shortages Decreases as Brexit Looms

The risk of post-Brexit drug shortages may be abating, European regulators say. Read More

Sanofi, Lexicon Draw Complete Response Letter for Diabetes Treatment

The FDA has pushed the pause button on Sanofi’s and Lexicon’s diabetes treatment Zynquista (sotagliflozin) two months after an advisory committee panel deadlocked over the drug’s safety profile. Read More

FDA Warns California Drugmaker for Sourcing from Sub-Standard CMOs

The FDA issued a warning letter to United Exchange Corp. for serious quality violations, including using products from “multiple sub-standard contract manufacturers” at its Cypress and Rialto drug manufacturing plants. Read More