This quarterly review on new drug applications contains data for applications approved for the first time during the fourth quarter of 2018 which includes New Molecular Entities (NMEs) and new biologics. A total of 46 applications were approved by ...
Thursday, October 11, 2018
This quarterly review on New Drug Applications (NDAs) contain data for applications approved for the first time during the second quarter of 2018, which includes New Molecular Entities (NMEs) and new biologics.
Wednesday, August 29, 2018
This quarterly review on New Drug Applications contains data for applications approved for the first time during the first quarter of 2018, which includes New Molecular Entities (NMEs) and new biologics. A total of 28 applications were approved by ...
Over the years, the Prescription Drug User Fee Act (PDUFA) has authorized the USFDA to collect user fees from industry to facilitate the review process for certain human drug applications. The fifth authorization of PDUFA (2012-2017) focused mainly ...
This column summarizes newly approved drugs, biologics, new indications and patient populations for already approved drugs from October to December 2017. This includes New Drug Applications (NDAs), Biologics Licensing Applications (BLAs) and ...
Saturday, February 10, 2018
This column summarizes newly approved drugs and new indications and
patient population for already approved drugs from June to September
2017. This includes New Drug Applications (NDAs), Biologics Licensing
Applications (BLAs) and Biosimilar ...
Thursday, December 07, 2017
This column summarizes newly approved drugs and new indications for already approved drugs from February to May 2017. This includes New Drug Applications (NDAs) for small molecules, Biologics Licensing Applications (BLAs), Medical devices and ...
Monday, September 25, 2017
Over the last 20 years, the PDUFA has authorized the USFDA to collect user fees from industry to facilitate the review process for certain human drug applications.
This column summarizes New Drug Applications (NDAs) approved in the November-December 2016 and January 2017. FDA approved 30 NDAs in these three months.
This column summarizes New Drug Applications (NDAs) approved in the September-October 2016 timeframe. FDA approved 20 NDAs in these two months.