While many people headed to summer vacation fun, FDA was busy in July, including a reorganization plan, new guidance documents for gene therapy development, efforts to prevent drug shortages, and more flexible import policies. FDA’s Biosimilars Action Plan (1), announced on July 18, 2018, may have the most implications for the market segment. In introducing the plan, FDA Commissioner Scott Gottlieb took innovator biopharmaceutical companies to task for impeding the delivery of biosimilar drugs to market (2). To date, only three of the 11 biosimilar drugs approved by FDA have reached patients, and the lack of competition in the biosimilar space cost US patients more than $4.5 billion in 2017, Gottlieb noted. Click Here For Complete Abstract Text
|
||||||||||||||||||
| Application Sequencing | ||||||||||||||||||
|
||||||||||||||||||
| Company | Product | Process | Other Subjects | Event | Event Date | Location | Publication | Publication Date | Text Descriptor | |||||||||
|
|
|
|
|
|
|
|
|
||||||||||