More NDAs, BLAs Filed in Q1 2019 Than Any Quarter in 2018
More new drug applications (NDAs) and biologics license applications (BLAs) were filed in the first quarter of FY 2019 than in any quarter in FY 2018, according to new real-time reports for pharmaceuticals that were mandated by the user fee legislation known as the Food and Drug Administration Reauthorization Act (FDARA).The latest report shows that 53 NDAs and 4 BLAs (57 total) were filed as of 31 December 2018, whereas the highest total for any quarter in FY 2018 was in Q1, when 46 NDAs and 7 BLAs (53 total) were filed. Q2, Q3 and Q4 of 2018 averaged about 30 NDAs filed and about 5 BLAs filed.
In terms of approvals (and not to be confused with novel drug and biologic approvals), 37 NDAs and 7 BLAs were approved in Q1 of FY 2019, which was less than all but two quarters last year. In Q4 FY 2018, 46 NDAs and 9 BLAs were approved, and in Q1 FY 2018, 43 NDAs and 8 BLAs were approved.
In addition to the filing and approval numbers, the FDARA reports include information on the number and titles of draft and final guidance related to human drug and biologics license applications and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.
The report also contains the number and titles of public meetings related to drug and biologics applications.
Other Reports
In addition to the NDA and BLA reports, FDA also publishes quarterly reports on medical device guidance and public meetings, as well as reports on generic drug and biosimilar guidance and public meetings.
Annual reports dating back to 2017 have also been published by FDA on inspections for drugs and devices, as well as a report on a public meeting from last April discussing clinical trial eligibility criteria to inform a guidance on this subject. And further guidance was published last May on the quality, safety and effectiveness of servicing devices.
Reports and Plans Mandated by FDARA