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The FDA will prioritize the opioid crisis, innovation, and generic competition in the coming year, the agency said in a 2018 Strategic Policy Roadmap released Thursday. Read More
The European Medicines Agency updated guidance on clinical investigations of rheumatoid arthritis drugs to add new endpoints and distinguish between patient subgroups in trials. Read More
Three South Dakota tribes sued two dozen drugmakers including Allergan, Teva and Purdue alleging the companies violated the Racketeer Influenced and Corrupt Organizations (RICO) act and engaged in fraud and deception in pushing their opioid products. Read More
CDER achieved numerous firsts in its past year of drug approvals, covering treatments for several rare diseases, cancer therapies and antibiotics. Read More
The House Energy and Commerce Committee released a review of the 340B drug discount pricing program, identifying weaknesses in oversight and administration, among other issues, and offering recommendations to resolve them. Read More