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Entries for the ‘Regulatory Affairs / Drug Approvals’ Category

Drug Approval Faster In US FDA Than Its European Or Canadian Counterparts

Although the drug approval process in the U.S. has been perceived as too slow, the nation approves new drug treatments faster and earlier than Europe and Canada, according to researchers at Yale School of Medicine. The study, conducted by Nicholas Dow…

Drug Safety Monitoring Should Be Expanded After Approval

Pharmaceutical drugs approved by the Food and Drug Administration (FDA) but later re-called from the market – such as the antidiabetic drug Avandia and pain-reliever Vioxx – were the impetus for an Institute of Medicine committee report, recommending t…

Financial Conflicts Of Interest – Does Disclosure Worsen Bias?

Last month, PLoS Medicine published an article of an examination of the financial conflicts of interest of members of the American Psychiatric Association (APA), which is responsible for updating the Diagnostic and Statistical Manual of Mental Disorder…

Monitoring Medications After Approval Has Improved Oversight, Says CDER

A more robust postmarket drug safety program has helped improve the FDA’s (Food and Drug Administration) oversight of medications after they have been approved, says a report issued by CDER (Center for Drug Evaluation and Research). CDER is part of the…

FDA Proposes Guidelines For Nanomaterials In Food And Cosmetics

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 documents are available for public comment for 90 days. The agency said in a Consumer Updat…

No BPA Ban On Cans And Food Packaging, Says FDA

Bisphenol A, also known as BPA will not be banned from cans and other food/drinks packagings, the Food and Drug Administration (FDA) announced yesterday, saying that those who requested the ban had not provided enough compelling data. The most appropri…

Caffeine "Inhaler" Maker Receives FDA Warning

On Tuesday, the US Food and Drug Administration (FDA) announced it had sent a warning letter to Breathable Foods Inc., makers of AeroShot, questioning the safety of their caffeine “inhaler” and accusing them of using “false or misleading statements …

Fake Avastin (Bevacizumab) Found In USA

Fake cancer drug, Avastin (bevacizumab) has been distributed in the USA, according to statement issued by Roche, Genentech and the FDA (Food and Drug Administration) today. Roche warns that the counterfeit medication does not have the active ingredient…

Carbendazim In Orange Juice – FDA Informs Juice Products Association

The following is an addendum to a FDA Letter to the Juice Products Association dated January 9, 2012. This information will be updated, as appropriate, on Friday of every week. January 27, 2012 The FDA is currently testing samples of orange juice ship…

FDA Approves Drug For Common Skin Cancer

On Monday, the US Food and Drug Administration approved a new type of drug to treat adult patients with advanced basal-cell carcinoma, the most common type of skin cancer. The drug’s generic name is vismodegib and was developed by the US part of Roch…