FDA Strives to Improve Post Approval Drug Safety

Recent reports have shown that the FDA is stepping up in strengthening the approval and research of post-approval drug safety. The administration has created a post market drug safety program that has shown to be extremely effective. The Center for Drug Evaluation and Research (CDER), the administration’s program, focuses on further research and testing of drugs once they’ve hit the American market. CDER has come out with new technology and research methods that have proven to be a success for both the drug makers and the administration. The program is also benefitting the public by releasing potential drug safety information much earlier, hoping to avoid patients from unknown side effects or problems. According to the FDA, “in 2011, CDER issued 68 drug safety communications – up from 39 in 2010. The communications provide early information to patients and health care professionals about drug safety issues as they emerge.”


The FDA is pleased to see that this program has benefitted not only the public, but their program as a whole. The administration feels programs similar to CDER will continue to emerge and increase the quality and effectiveness of keeping patients safe and informed in a timely manner. Though the administration has received pressure from several sources about the time it takes to clear medical devices, the FDA hopes with programs like CDER, medical devices and medicines will be cleared at a faster and safer rate. (read full article)

Not being properly informed about potential side effects of certain medications or deciding on a surgery with a medical device that little research has been done on, can lead to severe life changing problems, sometimes even death. One can never be too careful when it comes to taking medicine or undergoing surgery. Our firm has seen many patients suffer from the results of negligence when dealing with failed medical devices and harmful prescriptions.


At Borchardt Law Firm, we wish no family has to ever experience tragedies due to the negligence of pharmaceutical companies or health providers. However, with the experience our firm has, we feel the work we do will continue to better protect future generations of Texans. If you or a loved one have ever suffered from side effects and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might have. Borchardt Law Firm represent clients over many areas in Texas, feel free to give us a call.

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