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In response to an FDA warning letter about its placental-derived tissue product Axiofill, MiMedx Group defended its position that Axiofill is not a biologic drug and therefore not subject to additional oversight. Read More
The FDA approved 55 novel drugs and five biosimilars last year — substantially more than the 36 approved in 2022, according to the agency’s year-end report, but similar to the numbers approved in prior years. Read More
Sen. Bernie Sanders (I-Vt.), chair of the Senate Committee on Health, Education, Labor and Pensions (HELP), along with Democrats on the committee, has launched an investigation into the high price of asthma inhalers in the U.S., targeting four makers of the devices — AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK) and Teva Pharmaceuticals. Read More
This edition of Quick Notes looks at recent FDA Class I and company recalls involving patient return electrodes, pump-incompatible syringes, unintentional double drug dosing and missing zeroes. Read More
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