November 8, 2013 1:41 pm
Regulatory policy should be based on rules that are clear, with a process that is transparent, and on decisions that are accountable and reviewable, and that are congruent with other public policy imperatives.
August 14, 2013 6:27 pm
Licensed drugs have to go through rigorous trials. Even if an unlicensed drug works in some way, it might kill you in another way or cause problems.
June 18, 2013 2:47 pm
The Supreme Court rattled the pharmaceutical industry Monday when it ruled that antitrust regulators should be able to challenge the arrangements that allow rival drugmakers to delay the sale of a generic drug.
December 5, 2012 7:13 pm
The widely prescribed drug tamoxifen already plays a major role in reducing the risk of death from breast cancer. But a new study suggests that women should be taking the drug for twice as long could upend the standard that has been in place for about 15 years.
November 13, 2012 5:29 pm
Bioengineers at Harvard have developed a gel-based sponge that can be molded to any shape, loaded with drugs or stem cells, compressed to a fraction of its size, and delivered via injection. Once inside the body, it pops back to its original shape and gradually releases its cargo, before safely degrading.
June 6, 2012 12:04 pm
Doctors who treat cancer say a shortage of oncology drugs has eased, though shortages persist of some chemotherapy drugs that form the backbone of treatment for breast, colon, lung and some other cancers. Hospitals have been struggling with shortages of mostly older, generic drugs for cancer and other ailments for about two years.
May 17, 2012 9:51 am
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 15, 2012 10:40 am
A shift last year by the federal government in how it pays for drugs to treat dialysis patients may have had an unintended and potentially dire consequence, according to new research: a significant jump in blood transfusions for patients who now may not be getting enough of the medications. The findings are seen by some experts as a stark illustration of how the government’s reimbursement policies can drive the practice of medicine.
May 14, 2012 10:06 am
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 9, 2012 10:15 am
Two senior senators said on Tuesday that they had opened an investigation into financial ties between producers of prescription painkillers and pain experts, patient advocacy groups and organizations that set guidelines on how doctors use the drugs.