FDA Reports

All prescription drugs that desire to be marketed in the U.S. must gain the approval of the Food and Drug Administration (FDA). Through the Center for Drug Evaluation and Research (CDER), which assures that safe and effective drugs are available to the American people, a prescription drug must pass a series of trials. Please understand that the FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug's studies to the CDER so that the Center can evaluate its data. The studies answer the question, "Does this drug work for the proposed use?" By analyzing the data, CDER reviewers assess the benefit-to-risk relationship and determine if the drug will be approved. Once the drug has been placed on the market, the FDA continues to monitor it through post-marketing reports sent in by the manufacturer and through the MedWatch program - an FDA program that allows consumers and health care professionals to report serious side effects, quality control issues, and medical errors associated with drugs and products regulated by the FDA.

Sometimes, an unanticipated side effect manifests itself once the drug has been made available to the U.S. market. If the side effect is serious enough, the FDA may issue a warning to the public and request that changes be made to the drug's label. If the side effect is extremely serious and the FDA decides that the risks of the drug outweigh its benefits, then the FDA may recall the drug.

FDA Recalls
FDA Recalls

Information gathered from press releases and other public notices about recalls of FDA-regulated products.

FDA Warnings
FDA Warnings

This section includes drug marketing and advertising warning letters from the FDA to pharmaceutical companies.

FDA Alerts
FDA Alerts

MedWatch issues alerts from the FDA Safety Information and Adverse Event Reporting Program.



Food and Drug Administration

The FDA mission is to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws which are designed to protect consumers' health, safety, and pocketbook. Pharmaceutical drugs and medical devices must be safe and effective, radiation-emitting devices must meet established standards, and all products must contain informative and truthful labeling in English.

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Recent FDA Reports

FDA Statement On Tysabri Review Time

Biogen Idec and Elan announced on March 22, 2006, that the Food and Drug Administration (FDA) had extended the regulatory review period for the reintroduction of Tysabri (natalizumab) for multiple sclerosis (MS) by up to 90 days. Under the Prescription Drug User Fee Act, extensions to the review period for an application can be triggered…

Tysabri Q&A Regarding Lifting of the Clinical Hold

Why is FDA lifting the clinical hold? We received detailed information on the extensive re-examination that Biogen and Elan undertook on all patients who had received natalizumab in clinical studies under an IND. No additional cases of PML were identified. The better understanding of the actual occurrence of PML in these patients permitted better estimation…

Paxil Birth Defect Lawsuit

The FDA (Food and Drug Administration) issued a Public Health Advisory in December of 2005 that warned doctors and patients of the potential for Paxil (paroxetine) to cause an increased risk of congenital heart defects in infants due to exposure to Paxil in the womb. This FDA advisory was based upon two separate studies conducted…

Tysabri (natalizumab) Questions and Answers

What is Tysabri? Tysabri is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells, and play a role in immune system activity.   What is Tysabri used for? Tysabri is approved to treat patients with relapsing forms of multiple sclerosis (MS) to reduce…

FDA Issues Warning on Tysabri, a New Drug for MS

The Food and Drug Administration (FDA) today issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (nataluzimab) while the agency and the manufacturer evaluate two serious adverse events reported with its use. Tysabri, which received accelerated approval from FDA in November 2004, is an innovative treatment…

Suspended Marketing of Tysabri (natalizumab): Link to PML

FDA is issuing this public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (natalizumab) due to two serious adverse events reported with its use. FDA has received a report from Biogen Idec, the manufacturer of Tysabri, of one confirmed, fatal case and one additional case of progressive multifocal…

Tysabri Approved by the FDA for Multiple Sclerosis

First Monoclonal Antibody Treatment For Multiple Sclerosis Approved FDA today licensed a new biologic approach to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of symptom flare-ups or exacerbations of the disease. MS is a chronic, often disabling disease of the brain and spinal cord. Natalizumab, the new product, is…

Questions and Answers on Natalizumab

What is natalizumab? Natalizumab is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells, and play a role in immune system activity.   What are monoclonal antibodies? Antibodies are naturally occurring proteins produced by the immune system in response to foreign substances. Once…

Questions and Answers on Tysabri

What is Tysabri? Tysabri is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells, and play a role in immune system activity.   What are monoclonal antibodies? Antibodies are naturally occurring proteins produced by the immune system in response to foreign substances. Once…