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The FDA, EMA and Japan’s Pharmaceuticals and Medical Devices Agency have made strides toward aligning clinical trial designs for antibacterial drug indications, the regulators announced following their fourth tripartite meeting in Tokyo. Read More
The Department of Health and Human Services slapped Gilead with a patent infringement suit in a federal court on Tuesday over its HIV drugs Truvada and Descovy. Read More
The indications listed for opioid products must emphasize that opioids should only be used after other analgesics have been found to be ineffective, the agency said. Read More
Makena is the only FDA approved drug for preventing preterm birth in women who are pregnant with one child and have a history of preterm births. Read More
Submission of the information “as electronic data in structured data elements will improve the FDA’s ability to review and track the safety signals that occur during the conduct of clinical trials,” said CDER Director Janet Woodcock Read More
The Securities and Exchange Commission (SEC) issued a subpoena to Mallinckrodt in August for documents relating to the company’s lawsuit against the Centers for Medicare & Medicaid Services, the company disclosed on Tuesday. Read More