Friday, September 28, 2012

Drug Disposal - National Take-Back Initiative

Drug Disposal - National Take-Back Initiative:

"The Drug Enforcement Administration (DEA) has scheduled another National Prescription Drug Take-Back Day which will take place on Saturday, September 29, 2012, from 10:00 a.m. to 2:00 p.m. This is a great opportunity for those who missed the previous events, or who have subsequently accumulated unwanted, unused prescription drugs, to safely dispose of those medications.

The American people have again responded overwhelmingly to the most recent DEA-led National Prescription Drug Take-Back Day. On April 28th, citizens turned in a record-breaking 552,161 pounds (276 tons) of unwanted or expired medications for safe and proper disposal at the 5,659 take-back sites that were available in all 50 states and U.S. territories. When the results of the four Take-Back Days to date are combined, the DEA and its state, local, and tribal law-enforcement and community partners have removed over 1.5 million pounds (774 tons) of medication from circulation."

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Find the nearest take-back collection site in your area:
DEA - Take-Back Initiative Collection Site Search

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FDA told to act on wireless hacks

FDA told to act on wireless hacks | StarTribune.com:

"Wireless technology is creating new possibilities for implantable medical devices, from monitoring heart rhythms from a world away to adjusting the amount of insulin a diabetic receives.

But according to a just-released U.S. Government Accountability Office report, such technology has also opened the doors to hackers.

As a result, the GAO is calling for the U.S. Food and Drug Administration to develop a plan enhancing its surveillance of medical devices. Part of that process will place a sharp eye on information security."

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You might also be interested in:
Essentials for Medical Device Manufacturers - Live on-site QSR training - Learn the basics

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FDA warning public of risks of online pharmacies

FDA warning public of risks of online pharmacies - Businessweek:

"Research by the National Association of Boards of Pharmacy, which represents the state pharmacy boards, found that of thousands of online pharmacies it reviewed, only about 3 percent follow state and federal laws. In fact, the group's website lists only a few dozen Internet pharmacies that it has verified are legitimate and following the rules.

Most consumers don't know that. An Internet survey, conducted by the FDA in May, questioned 6,090 adults. It found that nearly one in four Internet shoppers has bought prescription drugs online, and nearly three in 10 said they weren't confident they could do so safely."

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For more information, visit the FDA's site and initiative:   FDA - BeSafeRx: Know Your Online Pharmacy

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Sunday, September 16, 2012

L'Oreal Hit by FDA Warning Letter for Questionable Claims

Cosmetic Company L'Oreal Hit by Warning Letter for Questionable Claims > RAPS > News - Article View:

"When does a cosmetic product become a drug? When it’s marketed as having advanced features that alter the body's cellular state, explained the US Food and Drug Administration (FDA) in a warning letter sent 11 September 2012 to Lancôme USA, a subsidiary of cosmetics manufacturer L'Oreal.

The letter references a number of products marketed by Lancôme, many of which claim to promote a more youthful look and go by names like, "Génifique Cream Serum Youth Activating Cream Serum" and contain modifiers such as "Precious Cells Advanced Regenerating and Reconstructing Eye Cream."

Claims Allegedly Violate Federal Regulations
In its warning letter, FDA said the products' claims, contained on Lancôme's website, make claims indicating that they affect the function and structure of the human body, which would make them a drug as defined by the Federal Food, Drug and Cosmetic Act."

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FDA Takes On Mobile Health Apps

The FDA Takes On Mobile Health Apps - IEEE Spectrum:

"But the public health agencies, big pharmaceutical companies, and start-ups that have pushed out apps in the past few years have outpaced U.S. government regulators. While it’s assumed that some medical apps are subject to regulations, the U.S. Food and Drug Administration (FDA) has not defined the scope of its oversight and has issued few enforcement actions. 


That’s about to change. The agency is expected to finalize guidelines within the next two months for medical apps, more than a year after releasing draft guidelines. For the industry, the expected rules bring both relief and trepidation: App makers are eager for clarity on how much red tape they’ll encounter in the future, but they’re also nervous that overly broad rules will stifle innovation. 


While waiting for the final guidelines to be published, we surveyed notable industry figures on what they’d like to see in the rules. Here are their top-five requests to the FDA. 
" . . .

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Wednesday, September 12, 2012

PharmTech Talk - LIVE from PDA FDA Joint Regulatory Conf 2012

PharmTech Talk » LIVE from PDA FDA Joint Regulatory Conference 2012:

"Be sure to follow our Twitter feed from this year’s PDA-FDA Joint Regulatory Conference, taking place in Baltimore, at Twitter@PharmTechAngie or Twitter@PharmTechGroup. Today’s sessions focused on common regulatory citations (the word is that they haven’t changed much in the past 10 years), new ways to handle internal investigations from Big Pharma organizations such as Amgen and Abbott (including a bit of an audience stirup surrounding the management, or lack thereof, of Class I investigations), FDA encouragement of sending novel excipients in for review, best practices for selecting excipients for new drugs (including how to best deal with suppliers), updates on ICH Q11, and a lot of information on knowledge management, risk-based approaches (including QbD), and lifecycle approaches."

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Tuesday, September 11, 2012

New FDA Device Helps ID Fake Drugs

New FDA Device Helps ID Fake Drugs:

"The FDA is using simple technology it designed to help nab counterfeit products, but the agency's development of such innovations may face trouble in the future, agency commissioner Margaret Hamburg, MD, said Monday.

The agency displayed its Counterfeit Detection Device No. 3 -- CD3 for short -- at an FDA symposium.

The device sprays 10 different wavelengths of visible and invisible light on products the FDA is inspecting. When they aim it over tablets, boxes, and accompanying documents, inspectors are able to spot counterfeit products and documents because they appear a different color or shade.

"It doesn't tell you what the problem is," explained R. Duane Satzger, PhD, director of the FDA's Forensic Chemistry Center. "It just lets you know there's a difference.""

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Monday, September 10, 2012

FDA Warns Dietary Supplement Firms to Stop Promoting Unapproved Products as Drugs

FDA Warns Dietary Supplement Firms to Stop Promoting Unapproved Products as Drugs:

"Under the Federal Food, Drug, and Cosmetic Act (FFDCA), a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. New drugs may not be legally marketed in the United States without prior FDA approval.  Although Neuro Impact, NeuroPruTect, and Omega3PruTect are marketed as dietary supplements, they are promoted as drugs through claims made on the firms’ websites.

“The FDA has taken these actions because companies may not sell new drugs unless the drugs have been tested by the sponsor and approved by FDA, and they may not make false or unsubstantiated claims about drugs they sell,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.”"

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