Monday, October 31, 2011

Should Mobile Medical Apps Require FDA Approval?

Should Mobile Medical Apps Require FDA Approval? - Healthcare - Mobile and Wireless - Informationweek:  ('via Blog this')

Mobile Medical Apps Meet The FDA, Part 2 - Healthcare - Mobile and Wireless - Informationweek: ('via Blog this')

A nice pair of articles, fairly and delicately balancing how much is enough, versus too much FDA regulation.

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

Related articles
Enhanced by Zemanta

Posted by Austin Lee at 8:15 PM 1 comments
Labels: , , , , , , , ,
Add Post To: | Digg| Technorati| del.icio.us| Stumbleupon| Reddit| BlinkList| Furl| Spurl| Yahoo| Simpy

Tuesday, October 11, 2011

OK Folks, Get Walking! Huge Health Benefits

Kaiser Permanente leader touts the myriad benefits of walking.



So what are you waiting for?!

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

Related articles
Enhanced by Zemanta

Posted by Austin Lee at 7:50 AM 0 comments
Labels: , , , , , , ,
Add Post To: | Digg| Technorati| del.icio.us| Stumbleupon| Reddit| BlinkList| Furl| Spurl| Yahoo| Simpy

Monday, October 10, 2011

FDA approves Cialis to treat benign prostatic hyperplasia

Tadalafil tablet (20 mg)Image via WikipediaPress Announcements; FDA approves Cialis to treat benign prostatic hyperplasia:   'via Blog this'

'nuff said.

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 

Related articles
Enhanced by Zemanta

Posted by Austin Lee at 7:50 AM 0 comments
Labels: , , , , , , , , , ,
Add Post To: | Digg| Technorati| del.icio.us| Stumbleupon| Reddit| BlinkList| Furl| Spurl| Yahoo| Simpy

Tuesday, October 4, 2011

Surviving FDA Enforcement Actions - Free Tips

http://www.cafepress.com/skillsplus/6793453
Life in FDA’s fast lane | News | Packaging World:  'via Blog this'

In the article, LeeAnn Rogus offers many tips. Here's just one of the many pearls of wisdom that's shared:
"The 15 days FDA gives a company to respond to a Form 483 inspectional observation has always existed, but the agency would usually let you have extra time. Not any more."
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 
Related articles
Enhanced by Zemanta

Posted by Austin Lee at 7:50 AM 2 comments
Labels: , , , , , , , , , , , , , , , ,
Add Post To: | Digg| Technorati| del.icio.us| Stumbleupon| Reddit| BlinkList| Furl| Spurl| Yahoo| Simpy
Subscribe to: Posts (Atom)
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