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The FDA has formalized its guidelines for sponsors seeking reconsideration of scientific or regulatory issues early in the approval process for generic drugs, issuing a guidance that also affirms the agency’s response-time pledges. Read More
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in an FDA program designed to help them through the approval process for new medicines, the agency said in finalizing draft guidance issued in 2015.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