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An FDA advisory committee voted Thursday to not recommend two regimens for Bayer’s inhalation-powder formulation of ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis, citing inconsistent data from clinical trials. Read More
The Senate gave final congressional approval to a bill designed to resolve a dispute involving FDA and the Department of Defense, preserving FDA’s authority over authorizing innovative medical treatments for soldiers while streamlining the process for granting the authorization. Read More
The FDA 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 will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to raise and the people who will participate in the meeting and includes other items spelled out by the agency in draft guidance, the FDA said. 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
In the first month of the GDUFA II program, the FDA sent 325 complete response letters to generics manufacturers — far more than the high of 190 seen in August of the fiscal year before. Read More