We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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drugmakers are calling on the FDA to include the use of physiologically-based pharmacokinetic (PBPK) modeling in its draft guidance on assessing the effects of food on drugs in INDs and NDAs.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
The FDA is requiring boxed warnings for certain prescription sedatives following reports of serious injuries and deaths linked to “complex sleep behaviors.” Read More
The House Rules committee on Tuesday held the first hearing on a proposal to create a national health program that would allow HHS to negotiate drug prices. Read More