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.
France’s Agency for the Safety of Health Products cited Chinese API manufacturer Chongqing Succeway Pharmaceutical for GMP non-compliance, including one critical finding — active tampering with company data. Read More
Missouri Gov. Eric Greitens (R) directed his health department to begin building a state prescription drug monitoring program to track prescribing and dispensing of several controlled drugs, including opioids. Read More
In the first trial verdict of thousands of similar suits, a federal jury ordered AbbVie to pay $150 million to a man who claimed the company’s testosterone drug AndroGel caused his heart attack. Read More
With just over two months left in the program, the FDA finalized a question-and-answer guidance for GDUFA I, covering ANDA reviews, inspections and self-identification of facilities. Read More
Some applicants surveyed said they were uncertain about the PRIME designation’s value, and felt it might limit their flexibility with other European regulators. Read More
The Reagan-Udall Foundation unveiled an online directory of dozens of pharmaceutical company policies on expanded access to investigational therapies. Read More