Tag: FDA

Blog Posts (24)

November 8, 2013

The Fat-That-Must-Not-Be-Named

by Craig Klugman, Ph.D.

As you may have heard, the FDA is considering changing its recommendations concerning partially hydrogenated oils, or what are commonly known as trans fats.…

February 8, 2011

Dirty Windows of Drug Development

Think of clinical trial data as a window on the efficacy and safety of a drug. Think of data protection and trade secrecy as soot. The above picture? This is the public view on drug safety and efficacy.According to a recent report in Nature Biotechnolo...
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.…

August 4, 2009

Bioethicist Charo Accepts Key FDA Post

University of Wisconsin law professor R. Alta Charo has accepted the post of senior adviser in the Office of the Commissioner of the FDA.…

July 19, 2009

It's Not August! But The August Issue of AJOB is Already Online at Bioethics.net

Now available at bioethics.net is the August issue of The American Journal of Bioethics.

This month’s issue contains articles ranging in topics from organ conscription and whether the US ought to have an opt-out system for organ donation and a number of thought experiments supporting that position by Delaney and Hershenov.…

May 29, 2009

Pucker Up!

Ladies, how much risk of lead exposure would you be willing to undergo for ruby red lips? Is it even something to be concerned about?…

May 27, 2009

Will Your Tweets Keep You Healthy Or Make You Sick?

Google has been tracking flu trends to monitor disease outbreaks for some time, but with the most recent outbreak of swine flu, social media has taken on a new role in the monitoring of health in our lives.…

View More Blog Entries

Published Articles (4)

American Journal of Bioethics: Volume 10 Issue 2 - Feb 2010

A Response to Commentaries on ?Blood Donation, Deferral, and Discrimination?

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

American Journal of Bioethics: Volume 8 Issue 4 - Apr 2008

Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance

American Journal of Bioethics: Volume 8 Issue 3 - Mar 2008

Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance

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.