Tuesday, July 27, 2010

Whooping Cough Outbreak In The US - CA Pertussis Hotspot

Logo of the Centers for Disease Control and Pr...Image via Wikipedia
Just in case you haven't heard, there's some kind of pertussis (whooping cough) epidemic in California. I live in California, and I take public transportation everyday. Call me phobic, and folks are coughing all around me without covering their mouths. The news about pertussis peaking resonates with me, as I've noticed within my workplace, many folks with peculiar and long-lasting coughs.

Pertussis (Whooping Cough) – What You Need To Know - From the CDC (Centers for Disease Control and Prevention).  This has some great links to audio files of what whooping cough sounds like.

Here are some Morbidity and Mortality Weekly Report (MMWR) - Notes from the Field: Pertussis --- California, January--June 2010

If you're really into learning more, from a science and medicine perspective, read this interesting Science-Based Medicine blog post, Californians give a whoop – or I hope they do.

Additional References:
The FDA webpages on Vaccines, Blood & Biologics

Return Home: http://drughealth.blogspot.com/
GMP Posters
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Enhanced by Zemanta

Tuesday, July 13, 2010

Promising New HIV Antibody Discovered



This is an exciting new finding.

For more details, read this Medical News Today article, Antibodies That Prevent Most HIV Strains From Infecting Human Cells Will Advance HIV Vaccine Design, Antibody Therapy For Other Diseases.

Return Home: http://drughealth.blogspot.com/
GMP Posters
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Monday, July 12, 2010

FDA - Impending 21 CFR Part 11 Inspections - Electronic Records

Get ready, here they come!

The FDA just announced, FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs, that they will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance). The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.

The guidance describes how FDA intends to exercise enforcement discretion and sets forth the following considerations related to Part 11:

  • Part 11 remains in effect since the issuance of the guidance and the exercise of enforcement discretion applies as identified in the guidance.
  • The guidance sets out certain conditions related to the validation, audit trail, record retention, record copying, and legacy systems where the Agency does not intend to take enforcement action to enforce compliance. Conversely, violations of part 11 requirements that do not fall within the guidance’s discretion can lead to enforcement action to enforce compliance depending on the importance of the violation.
  • Records must also be maintained or submitted in accordance with regulatory requirements outside of Part 11, and we will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.
You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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 

Tuesday, July 6, 2010

Google Medication Search

Logo for PubMed, a service of the National Lib...Image via Wikipedia
This should interest those of you looking up drug information on the web.

Google's new medications search feature displays ASHP's (The American Society of Health-System Pharmacists) consumer medication information, which is licensed by the National Library of Medicine.

Just Google a drug name and there it is!

Return Home: http://drughealth.blogspot.com/
GMP Posters
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Enhanced by Zemanta

From SkillsPlus International Inc.

Custom Search

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

FDA, GMPs, QSR, GCP, GLP, GXP:
    GMP Training Gifts & Giveaways