Tag:
user fees
Latest Headlines
Latest Headlines
Funding would allow FDA to target more foreign plants
If the FDA reauthorization bill is approved, the agency would be in line to get more money and more authority to inspect manufacturing plants around the world where 80% of the ingredients used in drugs now originate.
Conflict threatens as FDA user-fee bills near a vote
FDA user-fee legislation may be in the home stretch, but some proposals could slow it down as it nears the finish line.
Government, generic industry reach agreement on fees
After many years of negotiations with the U.S. government, the generic drug industry has agreed to pay $299 million in annual fees to allow for inspections of foreign manufacturing plants every two
Generic user fees gain traction with Hamburg's backing
It looks as if user fees really are in the offing for generic drugs. After generics makers said last week that they're supporting the idea as a way to speed approvals of their products, FDA
Generics makers aim to forge user-fee agreement
Generic drugmakers are getting their ducks in a row on user fees. At the end of the month, generics firms sit down with FDA to start hammering out a potential user-fee agreement. So, aiming to pick
Pharma, public critique FDA's performance
A new survey shows a disconnect between consumers' assumptions about FDA regulation and reality. And it illustrates the agency's difficult balancing act between serving the industry it oversees and
Drugmakers, groups lobby for user-fee changes
The FDA is already preparing to renegotiate the pharma user fees that expire in September 2012--and there are plenty of folks already trying to influence the process. To be fair, the agency has asked
