Tag: FDA
Blog Posts (28)
May 12, 2013
Judge Refuses to Drop His Order Allowing Morning-After Pill for All Ages
[New York Times] WASHINGTON — A federal judge on Friday stepped up his criticism of the Obama administration, accusing the Justice Department of making “frivolous” and “silly” arguments in its attempt to delay making the morning-after emergen...May 12, 2013
Judge Refuses to Drop His Order Allowing Morning-After Pill for All Ages
[New York Times] WASHINGTON — A federal judge on Friday stepped up his criticism of the Obama administration, accusing the Justice Department of making “frivolous” and “silly” arguments in its attempt to delay making the morning-after emergen...April 25, 2013
FDA Device Will Screen For Fake Medicines Overseas
[NBC News] WASHINGTON – U.S. health officials are making a high-tech screening device available to African authorities to help spot counterfeit malaria pills in hopes that the technology may eventually be used to combat the fake drug trade ...April 18, 2013
FDA’s Rejection Of Generic OxyContin May Have Side Effects
[NPR] Banning cheaper, generic forms of a dangerous drug sounds like a worthy idea. But the Food and Drug Administration’s decision to bar generic OxyContin may also push patients towards less effective drugs without eliminating the risk of addic...April 18, 2013
FDA’s Rejection Of Generic OxyContin May Have Side Effects
[NPR] Banning cheaper, generic forms of a dangerous drug sounds like a worthy idea. But the Food and Drug Administration’s decision to bar generic OxyContin may also push patients towards less effective drugs without eliminating the risk of addic...April 13, 2013
Study of Babies Did Not Disclose Risks, U.S. Finds
[New York Time] A federal agency has found that a number of prestigious universities failed to tell more than a thousand families in a government-financed study of oxygen levels for extremely premature babies that the risks could include increased ch...January 4, 2011
Coming Soon: Skull and Crossbones on Your Coke?
That purveyor of ideas all in the name of the “public’s interest”, the Center for Science in the Public Interest is calling for FDA Commissioner Margaret Hamburg to mandate warning labels on none other than your good ole’ soda pop.…
September 3, 2010
FDA and Office of Human Research Protection Respond to Fetal Dex Complaint
The September issue of The American Journal of Bioethics, presaged by such astonishing articles as “The Lesbian Drug” in Newsweek, stretched the boundaries of the Journal by engaging questions about the relationship between advocacy and scholarship, the meaning of transgressing boundaries in that regard, and the extraordinary implications of the social and medical debate concerning the administration of dexamethasone during pregnancy in females with congenital adrenal hyperplasia.…
August 31, 2010
Going to the Movies To Become a Little Less Fun....
When you snuggle down in your movie seat to watch your next action flick or romantic comedy with a barrel sized popcorn bucket and gallon of Coke at your side, your movie theater euphoria might be a bit diminished–if the FDA has anything to say about it.…
August 3, 2010
Geron Gets Green Light...Are the Floodgates Opening?
With the FDA approval of the first human stem cell trial from the Geron Corporation, there can be no doubt that dozens of other human clinical trials will quickly follow on its heels for approval for hESCs to be used in human beings to treat everything from spinal cord injuries to Alzheimer’s Disease to cancer.…
Published Articles (4)
American Journal of Bioethics: Volume 10 Issue 2 - Feb 2010
A Response to Commentaries on ?Blood Donation, Deferral, and Discrimination? Charlene Galarneau
American Journal of Bioethics: Volume 10 Issue 2 - Feb 2010
Blood Donation, Deferral, and Discrimination: FDA Donor Deferral Policy for Men Who Have Sex With Men Charlene Galarneau
American Journal of Bioethics: Volume 8 Issue 4 - Apr 2008
Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance Andy Gass
American Journal of Bioethics: Volume 8 Issue 3 - Mar 2008
Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance Andy Gass
News (7)
May 17, 2012 9:51 am
FDA panel backs at-home HIV test that analyzes mouth swab in 20 minutes (CBS News)
An at-home HIV test that claims to diagnose the disease in 20 minutes from saliva on a mouth swab is a step closer to hitting store shelves, now that an advisory panel of experts recommended the test kit’s approval to the Food and Drug Administration.
May 14, 2012 11:44 am
FDA Issues Warning About Experimental MS Therapy (ABC News)
CCSVI therapy, which has not yet been tested in clinical trials, consists of widening narrowed veins in the chest and neck through the use of balloon angioplasty or stents, both commonly used to treat atherosclerosis, or hardening of the arteries. The intervention is sometimes known as “liberation therapy,” or a “liberation procedure,” the agency said. But the FDA added that so far, it has not approved the use of balloon angioplasty devices or stents to treat CCSVI. It also encouraged clinical trials that could solidify the link between the two conditions, and urged patients to discuss the risks and benefits of CCSVI therapy with their doctors.
May 14, 2012 10:06 am
IOM calls for more thorough safety monitoring of drugs (American Medical News)
To track a medicine’s safety, the FDA should create a comprehensive benefit and risk assessment and management plan that is readily accessible to the public and easy to understand, according to the report, issued May 1. Such a document would give physicians and others greater access to information about drugs on the market than they had in the past, said Eric M. Meslin, PhD, a member of the 12-person IOM committee that wrote the report.
May 4, 2012 1:35 pm
FDA recommended to continue monitoring drugs' safety after approval (News-Medical)
The FDA-which asked the IOM to “convene a committee to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs”-already collects much of the suggested information, but the data are scattered across multiple records rather than amassed in one central location. “Decentralized records make it difficult for physicians, policy makers and consumers to easily assess information about risks and benefits that accrue over time,” Faden notes.
May 1, 2012 5:07 pm
Better Ways Needed to Track Drug Safety: Report (US News)
A management plan to gather, assess and respond to data about all medications’ risks from the time they are approved until they are no longer on the market is needed to improve drug safety in the United States, says an Institute of Medicine report released Tuesday.
April 22, 2012 11:57 am
FDA Proposes Guidelines For Nanomaterials In Food And Cosmetics (Medical News Today)
On Friday, the US Food and Drug Administration (FDA) proposed two new draft guidelines for the evaluation and use of nanomaterials in food and cosmetics. The agency said in a Consumer Update that this is the continuation of a “dialogue” that started in June 2011, when they issued a draft of the first guideline on the subject, one that helps industry decide whether an FDA-regulated product involves the use of nanotechnology, by considering for instance the size and properties of the materials.
March 26, 2012 1:34 pm
FDA Told to Act on Farm Antibiotics (Wall Street Journal)
A federal judge ordered the Food and Drug Administration to restart a process that could limit the use of two types of antibiotics in cattle, pigs and poultry, amid concerns such use leads to antibiotic-resistant infections in humans.