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 warned five firms in South Korea, China and Germany for various GMP violations, including problems with sanitation, facility procedures and complaint handling. Read More
The FDA issued two draft guidances aimed at implementing the Drug Supply Chain Security Act’s provisions for an electronic track-and-trace system for certain prescription drugs extending throughout the supply chain — one recommending data and documentation practices and another defining terms such as “suspect products” and “illegitimate products.” Read More
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials. Read More
The city alleged three opioid distributors contributed to the addiction epidemic by over-prescribing opioids and failing to report suspicious orders. Read More
Only three of the nine approved biosimilars in the U.S. have reached the market, with patent litigation often stalling launches even after approval. Read More
The FDA issued Kath Khemicals a Form 483 after an inspection of its Sterling Heights, Michigan facility revealed problems with batch reviews, product testing and cleaning, among other deficiencies. Read More
The FDA hit Chinese firm Zhejiang Ludao Technology with a warning letter after an August inspection revealed significant testing issues at its Taizhou, Zhejiang facility. Read More
A Gastrointestinal Drugs Advisory Committee panel voted unanimously in favor of including a 16-week induction dosing regimen of 10mg Xeljanz (tofacitinib) twice daily in patients who have not reached “adequate therapeutic benefit” by Week 8 on the product label. Read More
Switching from a reference medicine to a biosimilar does not affect patient safety, according to a data review by a research team that looked at 90 studies involving 14,225 subjects for signs of increased immunogenicity associated with switching. Read More