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In preparation for a September 2017 expiration, the FDA has scheduled a Dec. 18 public meeting to kick off reauthorizing the Biosimilar User Fee Act. Read More
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of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance.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