Saturday, April 12, 2014

Locator for National Prescription Drug Take-Back Day collection site available online | Drug Store News

Locator for National Prescription Drug Take-Back Day collection site available online | Drug Store News:

"the Drug Enforcement Administration National Prescription Drug Take-Back Day collection site locator allows consumers to search for a nearby location to dispose of unneeded medications on Saturday, April 26, 2014, the National Association of Boards of Pharmacy announced Wednesday. On April 26, from 10 a.m. to 2 p.m., thousands of DEA-coordinated collection sites will be available across the country, and consumers are encouraged to use this opportunity to safely and legally dispose of any unneeded pills, including prescription pain pills and other controlled substance medications, as these pills can only be accepted for disposal when law enforcement is present."

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Follow this link to find a collection site near you:  National Take Back Initiative Collection Site Search  

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Wednesday, April 9, 2014

Lovely Lilies and Curious Cats: A Dangerous Combination - FDA

Animal Health Literacy > Lovely Lilies and Curious Cats: A Dangerous Combination - FDA:

"It’s also important to remember that while lilies, a common household plant, are lovely to see and smell, they are still a safety threat for our cats. The entire lily plant (leaf, pollen, and flower) is considered to be toxic for cats. If you have lilies in your home this Easter, make sure that your cat doesn’t eat any part of the plants."

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Pharma needs ‘radical change’ says report | Pharmafile

Pharma needs ‘radical change’ says report | Pharmafile:

""Costs are sky-rocketing. Breakthrough innovation is ebbing. Competition is intense and sales growth is flattening," he adds.

It all adds up to investors attributing less value to companies’ pipelines, KPMG contends.

The perception of the pharma 'value chain' needs to change to a new 'value ecosystem' "which puts the patient and the customer at its centre, with other business services wrapped around their needs", KPMG believes."

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Monday, April 7, 2014

Sun Pharmaceutical to Buy Ranbaxy in $3.2 Billion Deal - WSJ.com

Sun Pharmaceutical to Buy Ranbaxy in $3.2 Billion Deal - WSJ.com:

"The deal would make Sun Pharma the largest pharmaceutical company in India and the fifth-largest generic drug company in the world. But it would also saddle the Mumbai-based company with the chore of fixing up Ranbaxy's operations and ending restrictions on its U.S. sales.

Before curbs imposed by the U.S. Food and Drug Administration, Ranbaxy earned about 40% of its revenue from the American market. Now, only one Ranbaxy plant, located in the U.S., is producing drugs for U.S. consumption."

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Friday, April 4, 2014

Health app users beware: Column - USA Today

Health app users beware: Column - USA Today:

"But how many are actually useful? An analysis by the IMS Institute for Healthcare Informatics found that only about 40% of those apps — 16,000 — are "truly related to health care" and oriented toward the consumer patient. Of those, two-thirds offered patients legitimate medical information."

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Sunday, March 30, 2014

Experts warn of the dangers of detergent packets (video)

Laundry packet hazards. Are your children safe?



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Diet drinks linked with heart disease, death - CNBC

Diet drinks linked with heart disease, death - CNBC:

"Researchers found women who drank two or more diet drinks a day were 30 percent more likely to have a heart attack or other cardiovascular "event," and 50 percent more likely to die, than women who rarely touch such drinks.

The findings, being presented at a meeting of the American College of Cardiology, don't suggest that the drinks themselves are killers. But women who toss back too many diet sodas may be trying to make up for unhealthy habits, experts say."

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Thursday, March 27, 2014

GlaxoSmithKline flags product tampering as wrong pills surface in alli packages - FiercePharma

GlaxoSmithKline flags product tampering as wrong pills surface in alli packages - FiercePharma:

"The tampered-with packages have cropped up in 7 states, GSK said, and sharp-eyed consumers have reported 5 different lot numbers. The rogue packages may appear to be authentic on the outside, but the bottle could contain a variety of tablets and capsules, the company said in a release.

Also, the suspect alli bottles may not be labeled, and tamper-evident seals may not be intact, or they may not match the official versions. Finally, lot numbers and expiration dates on the bottles and outer cartons don't match."

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Wednesday, March 26, 2014

Combination Products 101 - A Primer For Medical Device Makers - Med Device Online

Combination Products 101 A Primer For Medical Device Makers - Med Device Online:

"Most people have a very limited view of combination products. There are combination products under development today that involve many more things than just drugs, biologics, and medical devices. They involve foods. They involve nutraceuticals. They involve cosmetics, or so-called cosmeceuticals. They involve all kinds of technologies. From a regulatory perspective, these emerging combination products are going to present some real challenges for the future, because we don't have the regulation to support them."

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Tuesday, March 18, 2014

Patheon completes $2.65 billion merger with DSM | Pharmafile

Patheon completes $2.65 billion merger with DSM | Pharmafile:

"The amalgamation of the two contract development and manufacturing organisations (CDMOs) was first announced last November, when Patheon and its softgel capsule specialist Banner Pharmacaps combined with DSM’s pharma chemicals and contract manufacturing divisions to create a pharma outsourcing powerhouse.

DPx is now thought to be the second largest CDMO in the marketplace behind Catalent with around $2 billion in combined annual sales, and is 51% owned by Patheon’s private equity owner JLL Partners and 49% owned by DSM International. The combined company is headed by Jim Mullen, who was chief executive of Patheon."

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Friday, March 14, 2014

Pharma Cargo Theft Takes New Spike - FiercePharma Mfg

Pharma cargo theft takes new spike - FiercePharma Manufacturing:

"the trend has turned up again. The logistics and security company reported that in 2013, full-truckload pharmaceutical thefts jumped by 50% to 33 from 22, with the average loss up 14.15% to $261,819. Total pharma thefts, including last-mile cargo theft, spiked to 83, with an average loss of $180,346 in 2013. That was up from just 36, with an average loss of $153,697, in 2012. Last-mile thefts usually involve street criminals who rip off pharmacy delivery vans."

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Is the mythical "five-second rule" actually real? - CBS News

Is the mythical "five-second rule" actually real? - CBS News:

"New research finds that there is some truth to the so-called "five-second rule" -- the belief that food is safe to eat if picked up from the floor in under five seconds.

Researchers at Aston University in Birmingham, U.K. studied the rate of bacteria transfer in food items dropped on the floor and picked up within three to 30 seconds. They found that the amount of time an item spent on the floor was directly related to bacteria levels."

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GMP Trainers - Reasons To Get Your Own Training

  • It's important to learn the most effective ways to train your employees.
  • Never stop learning! Train & be trained as often as possible.
  • Your training toolbox should have a ton of things in it. 
"The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires." - William Arthur Ward
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Thursday, March 13, 2014

To prevent child poisoning, CDC says meds should be 'up and away' - USA Today

To prevent child poisoning, CDC says meds should be 'up and away' - USA Today:

"Budniz said that the message should be "up and away and out of sight" so kids aren't tempted by medicines.

Carr says caretakers should also make sure they don't have medications lying around in purses and coats, and to remember that "child resistant" does not mean "child proof." The government standard for child resistant is that 4 out of 5 children can't open the container within 10 minutes.

"With 64,000 children ending up in the emergency room for medicine poisoning each year, this is just a call that people must be extra vigilant," Carr said."

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Wednesday, March 12, 2014

Even a Few Drinks Tied to Poor Birth Outcomes - Medpage Today

Even a Few Drinks Tied to Poor Birth Outcomes - Medpage Today:

"Women who consumed low levels of alcohol before conception and during pregnancy were more likely to have adverse birth outcomes such as low birth centile, low birth weight, and premature birth than nondrinkers, a British study reported."

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Even More Resources, Books, & Things (many from Amazon.com)

FDA, GMPs, QSR, GCP, GLP, GXP:
21 CFR Parts 210 and 211: Drug Industry GMP's     Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)     The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices     Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)     How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations     Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance     How to Develop and Manage Qualification Protocols for FDA Compliance         Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)     Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices     FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics     Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)     Clinical Studies Management: A Practical Guide to Success     Analytical Chemistry in a GMP Environment: A Practical Guide     Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)     Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook     Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)     Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)     Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition     Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)     Cleaning Validation: A Practical Approach     Validated Cleaning Technologies for Pharmaceutical Manufacturing     Risk-Based Compliance Handbook     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)     Bioprocess Validation: The Present and Future     Laboratory Validation: A Practitioner's Guide     Quality Assurance Workbook for Pharmaceutical Manufacturers     Risk-based Software Validation: Ten Easy Steps     ISO 13485 and FDA QSR Internal Audit Checklist     ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Training Resources:
1001 Ways to Reward Employees     Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition     50 Creative Training Openers and Energizers     Personalized M&M Candies     Oriental Trading Co - Training toys and supplies     GMP Training Gifts & Giveaways     GMP Training & Quality Posters