Monday, October 31, 2011

Should Mobile Medical Apps Require FDA Approval?

Updated June 10, 2021

The links in the original post broke.

You can read more about this topic here:

---  the original post follows below  ---

Should Mobile Medical Apps Require FDA Approval? - Healthcare - Mobile and Wireless - Informationweek
:  

Mobile Medical Apps Meet The FDA, Part 2 - Healthcare - Mobile and Wireless - Informationweek

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

Monday, October 10, 2011

FDA approves Cialis to treat benign prostatic hyperplasia

Updated April 16, 2017:

The original link broke. You might also be interested in:
Tadalafil (Cialis) - (on MedlinePlus), and
FDA Approves Cialis to Treat Enlarged Prostate - WebMD

- -  original post follows below  - -

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

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

Tuesday, October 4, 2011

Surviving FDA Enforcement Actions - Free Tips

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors