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Showing 1 - 25ODAC Again Recommends FDA Withdraw Its Approval of Bevacizumab for Metastatic Breast Cancer
In June 2011, a public hearing was convened to consider an appeal of the December 2010 recommendation by FDA to remove the breast cancer indication for bevacizumab (Avastin). FDA’s recommendation late last year was in accordance with a July 2010 recommendation by the Oncologic Drugs Advisory...
FDA Commissioner Announces Decision on Bevacizumab
On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will still remain on the market as an...
FDA Announces Bevacizumab Decision: Agency Will Revoke Breast Cancer Indication
On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will remain on the market as an...
Bevacizumab Breast Cancer Indication Rescinded: What Are the Downstream Implications?
Leading up to FDA’s resolution to revoke the breast cancer indication for bevacizumab (Avastin), the debate over the drug’s clinical value was imbued with contentious ideologic overtones, which culminated in a 2-day public hearing that exposed deep divisions not only in the scientific community,...
FDA Completes Work on Three Drug User Fee Programs
The FDA recently completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biologic products to patients, according to FDA Commissioner Margaret A. Hamburg, MD. The programs include the fifth authorization of...
FDA Acts to Bolster Supply of Critically Needed Cancer Drugs
The FDA has announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. The President’s order, issued last October 31, directed the FDA to take action to help further prevent and reduce...
FDA Commissioner Statement: Surgeon General’s Report on Youth Smoking
The recent report on “Preventing Tobacco Use Among Youth and Young Adults” by the Surgeon General not only documents the devastating consequences of tobacco use for our nation’s youth, but also represents a clarion call for bold action at every level of government to implement proven strategies to...
FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported Products
FDA Commissioner Margaret A. Hamburg, MD, recently released the agency’s Global Engagement Report, detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. The report describes the steps the agency is taking to ensure that imported...
FDA Announces Decisions on New Tobacco Products
For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence pathway....
FDA Invites Public Input on Menthol in Cigarettes
The U.S. Food and Drug Administration (FDA) has issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes. Despite decades of work to reduce tobacco use in the United States, it continues to be the...
Molecular Tests and Precision Medicine: Not So Fast Now!
The era of the application of genomic, proteomic, and a host of other “omic” analyses to guide decision-making in the therapeutic selection of drugs and biologics is now a key part of cancer care. Medical practice is working to keep up with the scientific advances, evaluate them, and add a variety...
Straight Talk: The Future of Medical and Health Research
Nearly 200 scientists and stakeholders in the research community attended Research!America’s National Health Research Forum on September 12, at the Newseum’s Knight Conference Center in Washington, DC. Research!America’s President and CEO, Mary Woolley, opened the program. “The theme for this...
FDA Announces Class-Wide Safety Labeling Changes for Long-Acting Opioid Analgesics to Combat Abuse
The U.S. Food and Drug Administration (FDA) announced class-wide safety labeling changes and new postmarketing study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. “The FDA is invoking its authority to require safety labeling changes and postmarket...
FDA Proposes to Extend Its Tobacco Authority to Additional Tobacco Products, Including E-Cigarettes
On April 24, 2014, as part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration (FDA) proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products. Products ...
FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Call to Action to Prevent Skin Cancer
Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General’s Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun. Over the last few years, the FDA has taken a number of...
Surgeon General Call to Action to Prevent Skin Cancer
On July 29, 2014, the Surgeon General issued a Call to Action urging immediate action steps to prevent skin cancer. The report encourages increased awareness of the disease and calls for immediate and collaborative actions to reduce its risk. Nearly 5 million people are treated for skin cancer in...
FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests
The U.S. Food and Drug Administration (FDA) recently took important steps to ensure that certain tests used by health-care professionals to help diagnose and treat patients provide accurate, consistent, and reliable results. First, the FDA is issuing a final guidance on the development, review, and ...
FDA’s Janet Woodcock, MD, Receives Lifetime Achievement Award From the Institute for Safe Medication Practices
Janet Woodcock, MD, Director of the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, has been awarded the Institute for Safe Medication Practices Lifetime Achievement Award, which recognizes “an individual who has had a significant career history of making...
FDA Appoints Robert Califf, MD, Deputy Commissioner for Medical Products and Tobacco
U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, MD, has appointed Robert Califf, MD, as the FDA Deputy Commissioner for Medical Products and Tobacco. Dr. Califf is a leader in cardiology, clinical research, and medical economics, who is currently serving as Vice...
ASCO Commends Margaret Hamburg, MD, for Leadership as FDA Commissioner
ASCO expresses deep gratitude to Margaret Hamburg, MD, for her 6 years of vision and progress as Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Hamburg, one of the longest-serving FDA commissioners, leaves a legacy of important advances in regulatory science and medicine. The...
FDA Approves First Biosimilar Product Filgrastim-Sndz
The U.S. Food and Drug Administration (FDA) has approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States. A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar...
FDA Approves First Biosimilar Product Filgrastim‑Sndz
The U.S. Food and Drug Administration (FDA) today approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States. A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar...
FDA Proposes to Extend Its Tobacco Authority to Additional Tobacco Products, Including E-Cigarettes
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration (FDA) today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products. ...
FDA Announces Class-Wide Safety Labeling Changes for Long-Acting Opioid Analgesics to Combat Abuse
The U.S. Food and Drug Administration (FDA) today announced class-wide safety labeling changes and new postmarketing study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. “The FDA is invoking its authority to require safety labeling changes and ...
FDA Invites Public Input on Menthol in Cigarettes
The U.S. Food and Drug Administration (FDA) has issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes. Despite decades of work to reduce tobacco use in the United States, it continues to be the...
