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FDA Commissioner Scott Gottlieb spoke about the regulatory challenges of precision medicines and the agency’s plans to focus on durability and safety issues, in a panel discussion at the World Economic Forum in Davos, Switzerland. Read More
The stay will be either until March 30, until the guidance’s early publication, or an announcement that the guidance will be published after March. Read More
The FDA filed a joint motion with Endo to pause the company’s lawsuit accusing the agency of breaking the law with its decree authorizing bulk compounding of drugs. Read More
Drug sponsors can prove the effectiveness of combination drugs for treatment of hypertension with trials that test the highest approved dosage rather than trials with multiple doses, the FDA said in new draft guidance for developing such products. Read More
The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities and adopting a more flexible, risk-based approach to how often the agency will conduct inspections. Read More
The Food and Drug Administration teamed up with the Federal Trade Commission to issue joint warning letters to 11 marketers and distributors of opioid cessation products, for illegally marketing products with unproven claims of treating opioid addiction. Read More
If the product is mixed, diluted or repackaged in a state or federal pharmacy, it may only be distributed after receiving a valid prescription. Read More