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Acting FDA Commissioner Ned Sharpless had his coming-out party on Thursday at the Food and Drug Law Institute’s annual conference in Washington, D.C., where he reassured participants that, although there may be a new belle, the ball will go on as planned. Read More
Prescription drug costs would likely have a small impact on federal spending under a single-payer system but a national health system might have the unintended consequence of forcing drugmakers to stop taking risks on new medicines, the Congressional Budget Office says in a new analysis released Wednesday. Read More
Leading drugmakers are calling on the FDA to include the use of physiologically-based pharmacokinetic (PBPK) modeling in its draft guidance on assessing the effects of food on drugs in INDs and NDAs. Read More
Heron Therapeutics on Wednesday said they were sandbagged by federal regulators who issued a complete response letter for the company’s experimental anti-pain medicine. Read More
Accessing multi-jurisdictional data has been a challenge “because of differences in the requirements for requesting and accessing data and in the data themselves,” Canada’s Ministry of Health said. Read More