subject: Fda Also Approved Outsourcing Outsourcing Program Can Not Know [print this page] Now is the fact that many of the world's factory FDA never truly examined.
FDA inspected once every 2.7 years, pharmaceutical companies within the United States, but overseas pharmaceutical companies, the average check interval is 13 years. U.S. pharmaceutical companies have been aggrieved unequal treatment, but the FDA over the years in this area has not been any improvement.
However, the recent series of negative news for the FDA touched the FDA, it has finally action.
FDA has begun to lobby the U.S. Congress, wants Congress to approve the addition to using their own internal FDA official inspections other than the prosecutor, but also to the external acquisition of third-party prosecutors to implement the official FDA inspection. FDA finds that "mercenaries" this trick can be quickly resolved in the near future face of their checks must be greater than for the sharp contradictions. Now from the American public, the media, the medical profession, government pressure on the FDA has let the FDA Zhaojiabuzhu. FDA's this trick of course, backed by money, because Congress is about to nearly 300 million U.S. dollars additional funding, FDA that this outsourcing idea is to own the best out a prescription, they think of "medicine" to patients sure to addition .
However, when the FDA threw out the plan, quickly attracted a number of U.S. opposition, that the FDA simply does not work this trick. One of the most convincing reason is that shortly before the FDA to use a third-party Prosecutor Medical Devices Manufacturer inspections of the way, but in the end proved that this method does not work. FDA's counter to this argument is also showing his funny side, they said no one now can not find a very effective way to deal with more and more checks need to check the suppliers, in particular the number of suppliers is not only increasing And they come from more different countries. FDA officials said: "The fact is the world's many factories FDA has never truly examined. We now have a way to check so they do nothing stronger than it."
Opposition worried. FDA inspections of medical equipment on the fact that: each third-party inspector will be subject to FDA clearance training and examination only after induction. This process takes 2 years, so until now, FDA only 12 qualified third-party medical device prosecutors.
To FDA Burden There are many ways, such as in other developed countries have long Drug Administration FDA proposed mutual recognition of certificates with them the proposal. Thus, FDA can at least reduce from Europe, Japan, Australia and other countries, check the pressure, but this intermediate involves too many political factors other than medicine, so FDA has not indicated whether he wants this operation.
Now, with the U.S. presidential election draws near, FDA's outsourcing programs would ultimately be approved by Congress, is estimated to be known for the general election.
Fda Also Approved Outsourcing Outsourcing Program Can Not Know
