Thursday, August 21, 2014

UAVs Give New Meaning To Drug Delivery - Med Device Online

Read the full article: UAVs Give New Meaning To Drug Delivery: - Med Device Online

"A Palo Alto- and London-based startup company is developing unmanned aerial vehicle (UAV) technology with a new twist. Instead of performing remote surveillance or delivering explosives with surgical accuracy, they distribute payloads of medical supplies.

Reaching remote areas in developing countries can be difficult, especially in times of disaster. Roads may not be accessible, or a region may be quarantined due to an infectious disease "

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

What? No More Annual Pelvic Exams? - Medscape

Read the full article: What? No More Annual Pelvic Exams? - Medscape:

"No More Routine Pelvic Exams...Really?

I am a female general internist. I provide well-woman screening -- including "the" pelvic exam -- for the vast majority of my patients. That's why new clinical practice guidelines from the American College of Physicians (ACP),[1] based on a comprehensive systematic review of 68 years' worth of English-language evidence, really caught my eye. I read ACP's strong recommendation: "ACP recommends against performing screening pelvic examination in asymptomatic, nonpregnant, adult women." My first thought was, "Really?""

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Monday, August 18, 2014

Food additives on the rise as FDA scrutiny wanes - The Washington Post

Read the full article: Food additives on the rise as FDA scrutiny wanes - The Washington Post:

"The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration, which is responsible for ensuring the safety of chemicals streaming into the food supply.

And in hundreds of cases, the FDA doesn’t even know of the existence of new additives, which can include chemical preservatives, flavorings and thickening agents, records and interviews show.

“We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s deputy commissioner for food."

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Wednesday, August 13, 2014

India Outlines Plan to Boost Inspections of Drug Facilities - Pharmalot - WSJ

Read the full article: India Outlines Plan to Boost Inspections of Drug Facilities - Pharmalot - WSJ:

"Last year, the FDA conducted 111 inspections in India, up from 98 in 2011 and 59 in 2009, and has issued warning letters to several Indian drug makers. Significantly, the FDA also issued 21 so-called import alerts that allow the FDA to ban products from entering the U.S.

One widely known example is Ranbaxy Laboratories [500359.BY +1.16%], which is prevented from sending products from four of its plants in India and is also operating under a consent decree that requires improvements before the ban can be lifted. Sun Pharmaceuticals [524715.BY +1.46%] recently agreed to buy Ranbaxy for $3.2 billion"

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Wednesday, July 30, 2014

Quality of Dietary Supplements - QM USP

Read the full article: Quality of Dietary Supplements - QM (Quality Matters) USP:

"In the United States, current Good Manufacturing Practices (cGMPs) for dietary supplements are mandated by law, and the FDA has the authority to oversee dietary supplement companies for compliance with those GMPs. This provision of the law acts to safeguard consumers of some quality issues, helping to keep dietary supplements from becoming adulterated.

However, most quality specifications for dietary supplements in the United States are set by manufacturers with no premarketing oversight and few uniform requirements. For that reason, the quality of dietary supplements may vary significantly from one manufacturer to another.

Moreover, dietary supplements and their ingredients may be manufactured in countries with weaker regulatory systems making it even more difficult to control the quality of dietary supplements imported into our domestic market."

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Smart pill firm Proteus raises $172 million | Reuters

Read the full article: Smart pill firm Proteus raises $172 million | Reuters:

"A U.S. biotech company pioneering tablets containing embedded microchips that can tell if patients have taken their medication has raised a further $172 million, showing investor interest in its ingestible and wearable technology.

Privately held Proteus Digital Health, which is working with drugmakers including Novartis and Otsuka, said on Tuesday the funding was one of the biggest U.S. private financings this year and the largest in the digital health sector.

Proteus already has European and U.S. approval for its "smart pill" technology system, in which a tiny sensor is embedded in a tablet and linked to a patch worn on the patient's abdomen."

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Monday, July 21, 2014

Safety Alerts & Advisories > FDA Consumer Advice on Powdered Pure Caffeine

Read the full alert: FDA Consumer Advice on Powdered Pure Caffeine - FDA.gov:

"Key Message

The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products.  In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet.

The FDA is aware of at least one death of a teenager who used these products.

These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.

Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.

Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea or other caffeinated beverages."

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Wednesday, July 16, 2014

GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters

Read the full article: GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters:

"The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient investigation of unexplained discrepancies and deviations from defined standards and specifications in their inspections. The corresponding paragraph 21 CFR 211.192 requires that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments' understanding of deviations handling, failure investigations and corrective actions is frequently fragmentary."

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Monday, July 14, 2014

Spoonfuls can lead to medicine errors, study finds - US News

Read the full article: Spoonfuls can lead to medicine errors, study finds - US News:

"Parents who used spoonfuls "were 50% more likely to give their children incorrect doses than those who measured in more precise milliliter units," said Dr. Alan Mendelsohn, a co-author and associate professor at New York University's medical school.

Incorrect doses included giving too much and too little, which can both be dangerous, he said. Underdosing may not adequately treat an illness and can lead to medication-resistant infections, while overdoses may cause illness or side effects that can be life-threatening. The study doesn't include information on any ill effects from dosing mistakes."

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Wednesday, July 2, 2014

Buy, Store & Serve Safe Food > Eating Outdoors, Handling Food Safely - FDA.gov

Read the full article: Buy, Store & Serve Safe Food > Eating Outdoors, Handling Food Safely - FDA.gov:

"Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.

To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transporting your food to the picnic site, and preparing and serving it safely once you've arrived."

'via Blog this'

You might also be interested in:

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Friday, June 27, 2014

FDA approves 1st exoskeleton to help paralyzed walk again | MassDevice

Read the full article (and view video): FDA approves 1st exoskeleton to help paralyzed walk again | MassDevice:

"FDA regulators announced this evening that they approved for the U.S. market the 1st robotic exo-suit for helping patients with lower-body paralysis walk upright.

Called ReWalk , the motorized system is comprised of metal leg braces that strap around the legs and back, supplying movement to joints in the hips, knees and ankles. The system includes a watch-based remote that controls the suit's movements and patients rely on crutches to provide stability."

'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
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Custom Search

From SkillsPlus International Inc.

Custom Search

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