Not Recommended Internet Drug Sites - AWARxE

Read the full article & browse the list of sites: Not Recommended Sites - Safe Acquisition - Get Informed.® - AWARxE:

"Ordering drugs from these not recommended Web sites puts you and your family at risk.

Not Recommended Sites are those Internet drug outlets that appear to be out of compliance with state and federal laws or patient safety and pharmacy practice standards used by the National Association of Boards of Pharmacy® (NABP®). NABP has reviewed over 10,900 sites and found nearly 97% of those sites to be out of compliance."

'via Blog this'

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FDA Draft Guidance Summarized: Delaying, Denying, Limiting, or Refusing a Drug Inspection

• FDA cGMP QSR GMP Training - online training courses

Updated November 4, 2020

Some the links broke in the original post below.

You might also be interested in:

FDA Issues Draft Guidance on Definition of Denying, Delaying, Limiting or Refusing to Permit Inspection - The National Law Review

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA.gov (PDF)

- - -  original post follows below  - - -

Facility Inspection Guidance Issued by FDA: Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA Lawyers Blog:

" . . . in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as adulterated a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection". (emphasis added)"

Read the draft guidance:
FDA - Draft Guidance for Industry - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF)

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FDA cGMP QSR GMP Training - online training courses

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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The Exemptee Institute
The Designated Representative Institute

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FDA Patient Network - What We Do

What We Do | Patient Network:

"You can use this Web site to learn more about how FDA works and how you can participate in the drug and medical device approval process."

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

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

An Alternative To The Free Online GCP Training by Quintiles

• People also need recommended FDA GMP online training courses offered by SkillsPlus International Inc.

Free Online GCP Training

Updated 4/10/2015:

The Quintiles GCP training is no longer available to the public for free.

I recently discovered a free, publicly accessible GCP training program that might be of interest to you: The Good Clinical Practice (GCP) course, offered by the National Drug Abuse Treatment Clinical Trials Network

= = =

Free Online GCP Training | Clinical Research Learning Blog:  'via Blog this'

Upon completion of the program the participant will be able to:

1. Describe the ICH Good Clinical Practice (GCP) and local regulatory guidelines for good clinical practice in the conduct of clinical trials 
2. Discuss the investigator’s responsibilities in the conduct of clinical trials at the clinical site 
3. Apply ICH and local regulations to specific research activities at the clinical site

Free is good!

Quintiles helps pharmaceutical, biotechnology and medical device companies develop and market innovative therapies. Quintiles is also a full sized CRO and has its operations over more than 40 countries world wide.  

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

The Exemptee Institute
The Designated Representative Institute

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Flu.gov Updated by HHS - New Resources Added

The government's Department of Health and Human Services (HHS) unveiled several new resources on the federal government's one-stop resource for flu information -- https://www.cdc.gov/flu/. Some of the new items include:

• A self-evaluation guide
• A myth and facts section

Stay well!

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Asbestos.com - HONcode Certified

I've been doing a bunch of reading on mesothelioma and asbestos these days. It's hard to find balanced information. I often rely on the HONcode certification 'seal of approval' (principles) to help me discern more trusted sources of information. I mention this because I'm trying to find information sources that I think I can trust, such as Asbestos.com - The leading mesothelioma cancer resource. Do you rely on the HONcode? 

Related Posts: Reputable Mesothelioma Resources Are Nanoparticles Dangerous Like Asbestos? 

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