FDA has announced that it will hold a small business workshop on April 29, 2008 in Dallas Texas. We’ve been to a similar workshop in Washington, D.C. The FDA has a number of presentations but the discussions and questions are very limited. ATtendance is limited to 150 people and it is almost always sold out. [...]
Archive for March, 2008
One of the expected benefits of the new drug approval process under PDUFA is that drugs get approved within a certain timeframe, today about 10 months after submission. This often cited as a reason why generic companies are looking at 505(b)(2) - generic approval times are now stretching to 20+ months. Now comes the news [...]
