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.
Starting Oct. 1, pharma companies seeking to cash in on a rare pediatric disease priority review voucher must pay the FDA $2.727 million — $165,000 more than in the fiscal year ending Wednesday. Read More
Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More
Novartis Thursday launched a program to provide 15 drugs in Kenya, Ethiopia and Vietnam, with plans to eventually expand to 30 low- and middle-income countries. Read More
GlaxoSmithKline’s Aiken, S.C., plant received a four-observation Form 483 from the FDA for failing to follow quality control procedures and other GMP violations. Read More
Two new studies point to concerns over the FDA’s increasing use of expedited development and approval pathways — programs that rely on early-stage trials that produce less robust data. Read More
A qui tam lawsuit, unsealed Tuesday, alleges that Takeda used a sham clinical trial to obtain FDA approval for a new version of its gout drug Colcrys — raking in hundreds of millions of dollars as a result and delaying generic competition. Read More