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.
The FDA handed Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards. Read More
A group of Senate Democrats said they were willing to work with the incoming Trump administration to lower prescription drug prices and change the status quo. Read More
Six pharmaceutical companies are pushing for the dismissal of a False Claims Act suit by the City of Chicago over their promotion of opioids, arguing that the city has yet to provide factual evidence of any harm. Read More
UK’s antitrust agency has accused Actavis of breaching competition law by raising the price of generic hydrocortisone tablets for Addison’s disease by more than 12,000 percent since 2008. Read More
Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483. Read More
The type of postmarket safety report required for a combination medical product will be based on whether the product was approved through a drug, biologic, or device application, according to the FDA’s final rule published today. Read More