Newsletter - May 16, 2019
FDA is Increasingly Approving Drugs Based on One Clinical Trial Only
It has been a common assumption that one must conduct two or more pivotal clinical trials to support the NDA or BLA for a new drug or biologic. But it is not true. About a third of NDA and BLA applications for new products approved by FDA in 2018 were based on one clinical trial only. Read More
FDA Presents its Annual Report on Drug GMP: All is Average
FDA annual report on the “State of Pharmaceutical Quality” shows that most the manufacturing sites audited by FDA have an average score of between 7-8 out of 10. Two-thirds of all drugs sold in the US are manufactured in the US, India and China with the US-based sites accounting for about 40%, those in India about 13% and those in China about 12%. Read More
FDA is Increasingly Approving Drugs Based on One Clinical Trial Only
It has been a common assumption that one must conduct two or more pivotal clinical trials to support the NDA or BLA for a new drug or biologic. But it is not true. About a third of NDA and BLA applications for new products approved by FDA in 2018 were based on one clinical trial only. Read More
FDA Presents its Annual Report on Drug GMP: All is Average
FDA annual report on the “State of Pharmaceutical Quality” shows that most the manufacturing sites audited by FDA have an average score of between 7-8 out of 10. Two-thirds of all drugs sold in the US are manufactured in the US, India and China with the US-based sites accounting for about 40%, those in India about 13% and those in China about 12%. Read More
