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The FDA is taking public comments ahead of a United Nations meeting that plans to add 10 drugs to international lists of controlled substances, including several relatives of powerful street drugs. Read More
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