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The FDA yesterday proposed broadening its definition of the standard of evidence for effectiveness of investigational drugs and increasing the range of acceptable trial design, especially in rare disease research. Read More
The Association for Accessible Medicines said the changes “support open markets, greater competition and improved cost savings for patients.” Read More
The FDA on Wednesday released a new draft guidance that lays out a step-by-step process for applying data from a previously approved drug delivery system, a practice commonly known as bridging, to an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administration on Wednesday released its long-awaited proposed rule to allow states to import drugs from Canada — and a draft guidance for drugmakers who wish to import products they currently sell overseas.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