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One-quarter of the institutional review boards (IRBs) that oversee clinical research at medical schools have no written policy on potential conflicts of interest among members, and only one in five systematically collects information about members' potential conflicts of interest, according to a recent study.
Faced with soaring healthcare costs driven in part by biopharmaceutical therapies, federal policymakers should give the FDA power to approve follow-on biologics, AARP said.
PhRMA voiced opposition to proposed legislation that would create a pathway for the FDA to approve follow-on biologics because it will not ensure patient safety and will hinder innovation, the group said.
The HHS Secretary's Advisory Committee on Human Research Protections (SACHRP) has a new chairman, Samuel Tilden, following the resignation last November of Ernest Prentice.
Dermatology patients should avoid purchasing Roche's Accutane or its generic equivalents over the internet, according to safety warnings on a new FDA website detailing the dangers of buying the drug online.
Two leading House members sent a letter to FDA Commissioner Andrew von Eschenbach asking him when he would have to alert agency employees about possible layoffs if the Prescription Drug User Fee Act (PDUFA) is not reauthorized.
Wisconsin's ability to negotiate prices with drug manufacturers may come to an end, as the Centers for Medicare & Medicaid Services (CMS) wants the state to transform its prescription drug coverage plan for seniors into a Medicare-based program.
The FDA needs a more active drug safety surveillance system and more authority over drugmakers when it finds serious adverse events, according to a leading consumer watchdog group.