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."
'via Blog this'
For more information, visit the FDA's site and initiative: FDA - BeSafeRx: Know Your Online Pharmacy
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - Popular GMP training, effective QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store
Friday, September 28, 2012
FDA warning public of risks of online pharmacies
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."
'via Blog this'
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store
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." . . .
'via Blog this'
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR (medical devices) training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store
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."
'via Blog this'
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, superb QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store
Tuesday, September 11, 2012
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.""
'via Blog this'
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store
Posts
