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 hit Nexgen Pharma with a Form 483 after an inspection of its Irvine, California facility revealed procedural and documentation issues. Read More
API manufacturer Macfarlan Smith drew a Form 483 from the FDA for failing to ensure products manufactured at its Edinburgh, Scotland facility met current good manufacturing practice requirements. Read More
A Washington, D.C. law firm petitioned the U.S. Attorney’s Office in Boston to reopen an investigation of Forest Laboratories, claiming the company misrepresented clinical trial results used as the basis for Lexapro’s approval for pediatric use. Read More
ViiV Healthcare filed a patent infringement complaint against Gilead’s new HIV drug Biktarvy on the same day the combination drug secured the FDA’s approval. Read More
The FDA issued 35 new draft and 22 revised product-specific guidances for generic drugs, including the pain treatment buprenorphine, the skin disorder treatment fluocinonide and the multiple myeloma drug ixazomib citrate. Read More