PPH Lawsuit lawyer

The Food and Drug Administration Amendments Act of 2007

The FDA Amendments Act of 2007 was signed into law by President George W Bush on September 27th.

The new law is a significant addition to the FDA’s authority. The Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been expanded and re-authorized. These programs will guarantee that the FDA’s staff has the resources needed to conduct the complex reviews that are necessary for new drugs and devices.

In addition to the previous two laws, two other laws were reauthorized. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were reauthorized. These acts are intended to encourage more research into and more development of medical treatments for children. This is important as many drugs are not designed for use in people less than 18 years of age.

Generally speaking, the new law will provide substantial benefits for those who develop medical products and for those who use them.

In addition to the re-authorized bills, the FDA Amendments Act of 2007 also creates a requirement that pharmaceutical companies and medical device companies publish the results of their clinical studies in an online, FDA-monitored database. This is significant as it allows patients and doctors alike to see exactly what happened in clinical studies. Many drugs have had problems appear that were not disclosed to the public by their company. This will not happen now that the database is in place. Such drugs included Avandia and Vioxx.

If you have been diagnosed with primary pulmonary hypertension following treatment of diabetes with Avandia, contact the PPH lawsuit attorneys of Williams Kherkher at 1-800-220-9341 to discuss your case and to determine your legal options.