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The FDA launched a new search function on its website, designed to help users search for pharmaceutical quality-related guidances, compliance programs and manuals of policies and procedures (MAPP). Read More
The Biden Administration has signaled that it wants HHS to begin using the Defense Production Act (DPA) of 1950 to allow the government to invest in domestic manufacturing of essential medicines to shore up the drug supply chain. Read More
While the FDA has signaled concerns that drugs like Ozempic and Wegovy (semaglutide) come with an increased risk of suicidal ideation, a new study in the journal Nature says they don’t. Read More
How the FDA handles internal scientific disagreements and whether scientists have faced retaliation for expressing differing scientific views is the subject of a letter sent by the House Energy and Commerce Committee to the FDA. Read More
Just days after the FTC won a temporary injunction to halt IQVIA’s proposed acquisition of Propel Media’s DeepIntent healthcare advertising business, the companies have mutually agreed to abandon the proposed merger. Read More
The FDA has approved Florida’s plan to import drugs from Canada, making it the first state permitted to do so, after submitting its plan to the FDA in 2020. Read More
The FTC won its motion to temporarily block IQVIA’s planned purchase of California health advertising firm Propel Media, deeming further review by the commission would be in the public interest. Read More
The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances. Read More
The company was also named in five other warning letters this year aimed at companies selling unapproved and mislabeled drugs via Amazon’s site. Read More