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The FDA posted only 60 ANDA approvals in August — slightly below the year’s monthly average of 63 — plus 17 tentative approvals, an overall dip after a strong showing the previous three months. Read More
The FDA outlined its procedures for conducting filing reviews of ANDA applications, detailing the standards agency staff will use to judge whether a submission is sufficiently complete before beginning a formal evaluation. Read More
For fiscal 2017, the FDA approved 763 generic drug applications, beating the previous year’s record of 651 by 17 percent. An additional 174 were granted tentative approval. Read More
Drugmakers wishing to use emerging manufacturing technology should ask to participate in an FDA program designed to help them through the approval process for new medicines, the agency said in finalizing draft guidance issued in 2015. Read More
The European Medicines Agency has hit a snag in its efforts to publish clinical trial data reports, due to long pilot phases for the first publications it made after the policy took effect last October. Read More
A review of legal databases was unable find any liability lawsuits against pharmaceutical companies related to four years’ worth of products used under expanded access, according to a study by FDA researchers. Read More