The Health, Drug, Prescription, and GMP Supersite

FDA issues first social media rules for drug companies

noreply@blogger.com (Austin Lee) — Wed, 25 Jan 2012 16:08:00 +0000

amednews: FDA issues first social media rules for drug companies : Jan. 25, 2012 ... American Medical News:

"The Food and Drug Administration is giving pharmaceutical companies some rules for how they interact with consumers on social media. But the companies say they need a lot more clarification from the FDA before they're comfortable getting back online again.

The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format."

'via Blog this'

Read this draft guidance:
FDA - Guidance for Industry - Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF)

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store

Pot-based Prescription Drug Looks For FDA OK

noreply@blogger.com (Austin Lee) — Sun, 22 Jan 2012 17:44:00 +0000

This caught my eye. I had no idea there were products in the pipeline.

Pot-based Prescription Drug Looks For FDA OK | Fox News:

"A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists.

A British company, GW Pharma, is in advanced clinical trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents — a mouth spray it hopes to market in the U.S. as a treatment for cancer pain. And it hopes to see FDA approval by the end of 2013.

Sativex contains marijuana's two best known components — delta 9-THC and cannabidiol — and already has been approved in Canada, New Zealand and eight European countries for a different usage, relieving muscle spasms associated with multiple sclerosis."

'via Blog this'

New FDA Guidance - Physical-Chemical Identifiers for Anticounterfeiting

noreply@blogger.com (Austin Lee) — Sat, 21 Jan 2012 15:59:00 +0000

This just recently published by the FDA:

FDA Guidances (Drugs); Newly Added Guidance Documents:

Chemistry, Manufacturing, and Controls (CMC): Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 74KB - Final Guidance 10/11/11)

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store

Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA

noreply@blogger.com (Austin Lee) — Fri, 20 Jan 2012 15:51:00 +0000

Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA:

"Issued by the US Government Accountability Office, the new report says up to 40 percent of all pharmaceuticals sold in the US are actually manufactured overseas in countries like India and China. A whopping 80 percent of all ingredients used to manufacture drugs, including those manufactured in the US, reportedly come from overseas as well. And the FDA has inspected a mere 11 percent of all foreign drug manufacturing facilities, as opposed to the 40 percent it has inspected domestically."

'via Blog this'

Drug lobby wants clearer FDA rules for diet pills

noreply@blogger.com (Austin Lee) — Fri, 20 Jan 2012 14:55:00 +0000

Drug lobby wants clearer FDA rules for diet pills | Reuters:

"Over the past year, the FDA has drawn fire from some manufacturers for being too cautious in reviewing medical products, hindering U.S. innovation.

They point to obesity drugs, where Arena Pharmaceuticals, Orexigen Therapeutics and Vivus have hit roadblocks in gaining approval for their diet pills because of potential safety concerns."

'via Blog this'

FDA to weigh safety of tobacco lozenges, strips

noreply@blogger.com (Austin Lee) — Fri, 20 Jan 2012 02:54:00 +0000

I have mixed feelings. I know that I strongly dislike being around cigarette smoke. And I also understand the dangers and potential poisoning risks that these products pose.

FDA to weigh safety of tobacco lozenges, strips - USATODAY.com:

"Dissolvables" are flavored mints, strips and sticks of smokeless tobacco. These products are not stop-smoking aids. Instead, they are designed to allow people to satisfy their cravings for nicotine in places where smoking is banned."

'via Blog this'

US counterfeit drug seizures up 200 per cent in 2011

noreply@blogger.com (Austin Lee) — Fri, 20 Jan 2012 01:27:00 +0000

SecuringPharma - US counterfeit drug seizures up 200 per cent in 2011:

"China remained the primary source of counterfeit goods across all categories, representing 62 per cent of all seizures by value, with the value of pharmaceutical seizures from China increasing by more than $4.3m and the value of perfume seizures up $7m on the prior year.

Meanwhile, India and Pakistan both featured in the top 10 source countries in 2011, mainly due to seizures of counterfeit pharmaceuticals. Pharmaceutical seizures accounted for 86 per cent of the value of seizures from India and 85 per cent from Pakistan, said the CBP.

The top 10 source countries - in descending order - were: China; Hong Kong; India; Pakistan; Taiwan; Switzerland; Malaysia; South Korea; UK; and Mexico."

'via Blog this

America Is Drunk

noreply@blogger.com (Austin Lee) — Thu, 19 Jan 2012 15:50:00 +0000

America Is Drunk | Fox News:

"According to the Centers for Disease Control, we’re becoming a nation of drunks. Booze hounds on benders.

New data reveals that one in every six Americans downs eight mixed drinks within a few hours, four times a month. Twenty-eight percent of young people between the ages of 18 and 24 binge-drink five times a month, putting away seven drinks in one sitting. And 13 percent of those between the ages of 45 and 65 binge drink five times a month, too."

'via Blog this'

FDA Inspection Preparation

noreply@blogger.com (Austin Lee) — Wed, 18 Jan 2012 15:50:00 +0000

Don't get surprised! Prepare yourself well in advance of an FDA inspection.

But if you should find yourself on the brink of one in a week or so, here's something helpful:
Rapid Deployment Tips to Prepare for an Inspection Quickly by John Avellanet (PDF)

If you're not so much in a rush, then invest some time in getting prepared.

You might be interested in:
Surviving an FDA Inspection - a live onsite training class

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store

FDA Says Drug Shortages Raise Risk of Cancer Counterfeits

noreply@blogger.com (Austin Lee) — Wed, 18 Jan 2012 04:12:00 +0000

The FDA published this notice. Looks like drug shortages are opening doors for bad actors to take advantage of the situation.

FDA Notifies Health Care Providers about the Risks of Purchasing Unapproved Injectable Cancer Medications from Unlicensed Sources

Current shortages of injectable cancer medications may present an opportunity for unscrupulous individuals to introduce non-FDA approved products into the drug supply, which could result in serious harm to patients. Health care providers are reminded to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States (U.S.).

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store

College-age adults average 9 alcoholic beverages when they binge drink

noreply@blogger.com (Austin Lee) — Mon, 16 Jan 2012 15:50:00 +0000

Image via Wikipedia

This was somewhat thought-provoking. . . if you go to a dinner party and have 4-5 or more glasses of wine over at least that number of hours, does that also qualify as binge drinking? hmmm

College-age adults average 9 alcoholic beverages when they binge drink, CDC report says - The Washington Post:

"College-age drinkers average nine drinks when they get drunk, government health officials said Tuesday. That surprising statistic is part of a new report highlighting the dangers of binge drinking, which usually means four to five drinks at a time. Overall, about 1 in 6 U.S. adults surveyed said they had binged on alcohol at least once in the previous month, though it was more than 1 in 4 for those ages 18 to 34."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store

Food Facility Audits Largely Ignore FDA Guidance

noreply@blogger.com (Austin Lee) — Wed, 11 Jan 2012 18:47:00 +0000

Food Facility Audits Largely Ignore FDA Guidance | News | Manufacturing.net:

"The present audit system is fraught with conflicts and is designed not to find safety problems, but to keep food — regardless of quality — flowing from farm to fork," he said"

'via Blog this'

MediBabble - Medical Translation at Your Fingertips

noreply@blogger.com (Austin Lee) — Wed, 11 Jan 2012 15:54:00 +0000

I just learned about this the other day, and thought I'd share this with everybody.

MediBabble in the Press:

"MediBabble is an impressively powerful and comprehensive (and free!) mobile medical interpretation tool with great utility for clinical settings — a true must-have for any individual involved with health care delivery!"

'via Blog this'

FDA Audit Preparation

noreply@blogger.com (Austin Lee) — Mon, 09 Jan 2012 15:50:00 +0000

Image via Wikipedia

The folks from Emergo Group have a very nice outline of how to think and approach FDA inspection readiness, before the FDA actually shows up at your door.

Preparation for an FDA Quality System Audit - from Emergo Group:

"In order to meet US Food and Drug Administration (FDA) requirements, medical device manufacturers active in the US market must undergo FDA audits of their quality management systems to demonstrate compliance with Quality System Regulation 21 CFR Part 820, also known as Good Manufacturing Practice (GMP)."

'via Blog this'

You might also be interested in:
Surviving an FDA Inspection by SkillsPlus International Inc.

FDA Antibiotic Ban is Too Little, Too Late

noreply@blogger.com (Austin Lee) — Sat, 07 Jan 2012 15:20:00 +0000

Antibiotic Ban is Too Little, Too Late - NYTimes.com:

"To recap, the F.D.A. will partially ban a disappearing family of antibiotics that is relatively non-existent in animal agriculture and that the meat industry does not rely upon. Not exactly a bold move. Kind of like protecting less than 1 percent of the acreage in the rainforest or 1 percent of the fish in the sea while allowing producers to devastate the rest, and patting yourself on the back to boot."

'via Blog this'

27 Hot Drugs Facing FDA Approval in 2012

noreply@blogger.com (Austin Lee) — Sun, 01 Jan 2012 18:17:00 +0000

27 Hot Drugs Facing FDA Approval in 2012 - TheStreet:

"Here's an updated look at the biotech and pharmaceutical companies with pending FDA drug approval decisions in 2012."

'via Blog this'

FDA ramps up role as safety sheriff

noreply@blogger.com (Austin Lee) — Mon, 26 Dec 2011 17:35:00 +0000

FDA ramps up role as safety sheriff - Omaha.com:

"The federal Food Safety Modernization Act will result in numerous changes — some large, some small — for food manufacturers and farmers in 2012 and beyond as the Food and Drug Administration continues its slow, steady rollout of new regulations. During the new law's first year, little has changed other than sweeping educational efforts to prepare farmers and food manufacturers for ramped-up federal inspection efforts. The inspections will include more, and increasingly intense, reviews of food safety and health protocols. But for 2012 and beyond, companies are preparing for financial effects. Over the next five years, the FDA is planning to issue more than 50 new rules, add inspectors and ramp up oversight efforts to the tune of $1.4 billion."

'via Blog this'

Happy Holidays!

noreply@blogger.com (Austin Lee) — Sat, 24 Dec 2011 18:28:00 +0000

Wishing all of you a safe and heartfelt holiday!

2012 Predictions for Global Supply Chains

noreply@blogger.com (Austin Lee) — Tue, 20 Dec 2011 15:50:00 +0000

Supply Chain Matters Blog 2012 Predictions for Global Supply Chains- Part One | Supply Chain Matters:

"We will kick-off this series with the full listing of our ten predictions for the upcoming year. In upcoming postings, we will provide the detailed thoughts supporting each prediction."

'via Blog this'

You might also be interested in:
Auditing: Internal and External Customers and Suppliers - training by SkillsPlus International Inc.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store

2012 Crystal Ball Predicts a More Aggressive FDA

noreply@blogger.com (Austin Lee) — Mon, 19 Dec 2011 15:50:00 +0000

2012 Crystal Ball Predicts a More Aggressive FDA:

"According to the FDA website, 2012 will be a year of global regulatory operation and enforcement with emphasis on medical devices, drugs, and food products. "

'via Blog this'

The article references:

The FDA Pathway to Global Product Safety and Quality

It's hard to believe 2011 is nearly over, and 2012 is around the corner. Here's to future trends!

FDA Crackdown on Viagra-Like Supplements

noreply@blogger.com (Austin Lee) — Thu, 15 Dec 2011 15:54:00 +0000

FDA Crackdown on Viagra-Like Supplements - Video - Bloomberg:

"The discovery came during a Food and Drug Administration inspection that’s part of an expanding crackdown by the agency on the $28 billion supplement industry."

'via Blog this'

My gut sense tells me that this is just the tip of the iceberg, a problem of enforcement that the FDA will be hard pressed to wrap their arms around.

FDA Update - HCG Diet Products Are Illegal

noreply@blogger.com (Austin Lee) — Tue, 13 Dec 2011 15:50:00 +0000

Consumer Updates; HCG Diet Products Are Illegal:

"The Food and Drug Administration (FDA) is advising consumers to steer clear of these "homeopathic" human chorionic gonadotropin (HCG) weight-loss products. They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores. "

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store

You might be interested in these items:
Tiger Woods TW Cap BLACK Size M/L
Shop Amazon's Christmas Corner - Holiday decor, tableware, and entertainment
Visit Our Baking Store for Holiday Cooking Products
Wine Lovers Dishwasher Magnet

FDA Refreshes Website

noreply@blogger.com (Austin Lee) — Mon, 12 Dec 2011 15:50:00 +0000

FDA-approved hangover pill

noreply@blogger.com (Austin Lee) — Mon, 05 Dec 2011 15:50:00 +0000

Cheers! FDA-approved hangover pill promises to take edge off holiday partying - NY Daily News:

"A new FDA-approved hangover cure has hit the market just in time for holiday party season."

'via Blog this'

This new product is called Blowfish:

What is GMP?

noreply@blogger.com (Austin Lee) — Mon, 28 Nov 2011 15:50:00 +0000

What is GMP?:

"GMP means something different when in different regions of the world."

'via Blog this'

You might also be interested in:
Essentials for Pharmaceutical Manufacturers - a SkillsPlus International Inc. a cGMP training class

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store

The Health, Drug, Prescription, and GMP Supersite

FDA issues first social media rules for drug companies

Related articles

Pot-based Prescription Drug Looks For FDA OK

New FDA Guidance - Physical-Chemical Identifiers for Anticounterfeiting

Related articles

Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA

Drug lobby wants clearer FDA rules for diet pills

FDA to weigh safety of tobacco lozenges, strips

US counterfeit drug seizures up 200 per cent in 2011

Related articles

America Is Drunk

Related articles

FDA Inspection Preparation

Related articles

FDA Says Drug Shortages Raise Risk of Cancer Counterfeits

College-age adults average 9 alcoholic beverages when they binge drink

Related articles

Food Facility Audits Largely Ignore FDA Guidance

MediBabble - Medical Translation at Your Fingertips

FDA Audit Preparation

Related articles

FDA Antibiotic Ban is Too Little, Too Late

27 Hot Drugs Facing FDA Approval in 2012

FDA ramps up role as safety sheriff

Related articles

Happy Holidays!

2012 Predictions for Global Supply Chains

Related articles

2012 Crystal Ball Predicts a More Aggressive FDA

FDA Crackdown on Viagra-Like Supplements

Related articles

FDA Update - HCG Diet Products Are Illegal

FDA Refreshes Website

FDA-approved hangover pill

Related articles

What is GMP?