Showing posts with label faq. Show all posts
Showing posts with label faq. Show all posts

Monday, September 28, 2020

FAQ: What is a California Designated Representative training affidavit?


According to the article:

"The training affidavit is proof of required training.

In general, individuals applying for a designated representative license in California must submit proof that they have completed required training as specified on their applicable license application Training Affidavit form."

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California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc. -  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses. Approved by the California State Board of Pharmacy

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Friday, August 16, 2013

Medical Foods > FDA Draft Guidance for Industry: FAQs 2nd Ed

Medical Foods > Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition:

"The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses; new questions and answers and amended responses are identified by the date they were added to the guidance."

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Thursday, September 8, 2011

21 CFR 11 Questions and Answers

Compliance Zen: Recent 21 CFR 11 Questions and Answers:  'via Blog this'

A nice collection of things you should know about 21 CFR 11 by John Avellanet.

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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!












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Friday, November 6, 2009

FDA FAQ On IV Peramivir To Treat H1N1 Flu

Updated October 24, 2023

The original links broke.

You might also be interested in:

---  the original post follows below  ---

Recently, the FDA Says Yes to IV Peramivir To Treat Flu. Now here's the FDA followup with Peramivir IV Questions and Answers for Health Care Providers. It's a pretty comprehensive collection of over 20 questions and answers, and concludes with a set of related links. 

Friday, April 24, 2009

EPA Attacks Nasty Bed Bugs!

Updated October 30, 2021:

Alas, the Harvard School of Public Health links in the original post didn't age well, and are invalid.

You might also be interested in this:
Infestations of bed bugs are on the increase... by Harvard Univ. (PDF)

= = =  original post follows below  = = =

I'm totally grossed out. Although I've never actually seen a bed bug, my skin crawls when I think about them. If you haven't seen one, checkout this WebMD Bed Bug Slideshow. The EPA (Environmental Protection Agency) just hosted its first meeting to figure out how to respond to the biggest bedbug outbreak since World War II. One of the problems with controlling the reddish-brown insects, according to researchers and the pest control industry, is that there are few chemicals on the market approved for use on mattresses and other household items that are effective at controlling bedbug infestations. Interestingly enough, because the registration of new pesticides takes so long, one thing the EPA could do is to approve some pesticides for emergency use. The pesticide industry will be pushing for federal funding for research into alternative solutions, such as heating, freezing or steaming the bugs out of bedrooms.

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Monday, December 22, 2008

FDA - FAQs About Combination Products

If you're just getting into the regulations that govern combination products, or need a quick refresher, then check out this collection of FDA Frequently Asked Questions about combination products, published by the FDA. 

Thursday, September 4, 2008

FDA Orange Book - Online

FDA Orange Book - Online

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

- -  original post follows below  - -

In case you didn't know, the FDA's Orange Book is now available online. The folks at Foley & Lardner LLP state, "The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, was introduced in 1979, and since its introduction has unquestionably been the authoritative reference source for drug products approved by FDA under the Federal Food, Drug & Cosmetic Act. No longer a printed book, but a database available on FDA's website, the Orange Book lists all products that have been approved by FDA for safety and effectiveness, and explains the therapeutic equivalence code for multi-source products." The FDA website makes the following Orange Book resources available to you . . .
  1. Orange Book Query - The Electronic Orange Book Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number.
  2. Orange Book Annual Edition (28th Edition) - The publication identifies drug products approved on the basis of safety and effectiveness.
  3. Orange Book Current Cumulative Supplement - The monthly Cumulative Supplement publication provides information on newly approved drugs, changes and revisions to current data including therapeutic equivalence evaluations, and updated patent and exclusivity data.
  4. Orange Book - Information and Data Files - Text files for importing into databases.
  5. Orange Book Monthly Additions and Deletions - Changes to the annual edition are listed separately by month.
  6. Frequently Asked Orange Book Questions
  7. Frequently Asked Patent and Exclusivity Questions
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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
The Health, Drug, Prescription, and GMP Supersite Gift Store 

From SkillsPlus International Inc.