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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
The FDA invited comments on a draft guidance that outlines what the agency considers best practices for postmarket safety surveillance for drugs and biologics. Read More
The FDA has begun the second phase of its CDER reorganization efforts aimed improving drug reviews, including three new offices to handle medicines for cancers, infectious diseases and neurological disorders. Read More
The agency said further confirmatory testing should be conducted on products that are at risk of being contaminated with the potential carcinogen. Read More