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The FDA on Wednesday released a new draft guidance that lays out a step-by-step process for applying data from a previously approved drug delivery system, a practice commonly known as bridging, to an application for a combination product. Read More
A small provision in Congress’ bipartisan budget deal expanding the definition of biosimilars has received praise from the FDA, who said the move could help improve access to insulin and other protein products. Read More
The FDA’s Oncologic Drugs Advisory Committee voted unanimously on Wednesday to recommend approval of Epizyme’s tazemetostat for treatment of metastatic or locally advanced epithelioid sarcoma not eligible for surgery. Read More
Promising lower drug prices, the administration on Wednesday released its long-awaited proposed rule to allow states to import drugs from Canada — and a draft guidance for drugmakers who wish to import products they currently sell overseas. Read More
Stephen Hahn was sworn in as the FDA’s 24th commissioner by HHS Secretary Alex Azar Tuesday evening and he will make his debut appearance as commissioner to the agency’s staff on Friday. Read More
The FDA hit RAM Pharma, a drug compounding and outsourcing firm, for numerous failures at its Idaho Falls facility, including repeat findings of microbial growth and lax air sampling. Read More
Members of the Senate Judiciary Committee spent a good portion of a hearing on the opioid crisis yesterday grilling a senior Drug Enforcement Agency official on the agency’s tracking of opioids. Read More
The FDA’s Oncologic Drugs Advisory Committee voted 9-4 yesterday to recommend approval of Merck’s Keytruda (pembrolizumab) injection for treatment of certain patients with bladder cancer who are ineligible for surgery or have opted out. Read More
The House voted 297-120 yesterday to approve a fiscal 2020 federal budget that includes $3.16 billion in discretionary spending for the FDA — $91 million more than in fiscal 2019 — and a total agency budget of almost $5.8 billion including user fees. Read More