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The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said June 1, adding that the current system of different expectations is not sustainable. Read More
Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drugmakers to pay state Medicaid rebates when prices rise faster than inflation. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
The Goldwater Institute is suing the FDA after it denied the group’s Freedom of Information Act request for information on the process the agency used in allowing two Americans to be treated with an investigational anti-Ebola drug. Read More
The European Medicines Agency Wednesday released final guidance on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More
The FDA has granted breakthrough therapy status for Genentech's scleroderma treatment Actemra, guaranteeing the drug a six-month review rather than the usual 10 months. Read More
The Australian government has developed a framework for measuring the performance of its regulatory agencies, in an effort to increase transparency and cut down on practices that impede the operations of regulated industries. Read More
The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug. Read More