美FDA自1827年成立以来一共批准了多少药物?
自1827年FDA成立截至2013年最后一天,一共186年间,共批准1453个药物,平均一年7.8个。跟建国后我们CFDA批准的中成药数量比一比那是太弱了。这是一篇论文,整理了大量的资料而得出的详细数据。
An overview of FDA-approved new molecular entities: 1827 ..
How Many Drugs has FDA Approved in its Entire History ...
Highlights
- •1453 new molecular entities (NMEs) approved as therapeutics in the USA.
- •As a consequence of consolidation, ten companies control more than two-thirds of all NMEs.
- •Trend – accumulation of NMEs by companies with little internal R&D capabilities.
The modern pharmaceutical industry began in earnest during the 1930s," the authors note. "The rate of NME approvals of
this nascent industry remained at a relatively low level (averaging fewer than four NMEs per year) until 1950."
Thereafter, FDA began to regularly approve in excess of 10 NMEs each year until the 1980s,
when it began to regularly approve more than 20 NMEs each year. Its approval rate peaked in 1997,
when the agency approved a whopping 55 NMEs—a number the agency has never again come close to matching.