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The FDA is clearing up its annual reporting requirements for wholesale distributors and third-party logistics providers (3PL), explaining who must report and when to submit filings, among other clarifications, in a draft Q&A guidance. Read More
The FDA approved Egalet’s extended-release morphine tablet, Arymo ER, for daily, around-the-clock pain treatment, with specific labeling describing physical properties that can deter abuse through injection. Read More
The Supreme Court has rejected Mylan’s challenge to a Federal Circuit decision that generic-drugmakers can face patent suits anywhere they may make sales in the future. Read More
The International Generic Drug Regulatory Program has outlined the group’s priorities for the next four years, focusing on five initiatives geared toward harmonizing global regulations on generic drugs. Read More
The EMA is clarifying agency expectations on the implementation of risk-based models and exposure limits to prevent cross-contamination during manufacturing in a Q&A guideline, telling manufacturers that all products should have health-based exposure limits (HBEL). Read More