Pick the wrong Medicare drug plan and the cost will shock you - CNBC

Read the full article:   Pick the wrong Medicare drug plan and the cost will shock you - CNBC:

"As prescription drug prices continue their upward climb, Medicare beneficiaries should pay close attention to the coverage they choose during open enrollment." ...  "Either way, experts say that while you should ensure that any medications you take are covered, don't stop your search at the first choice meeting that basic minimum."

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Nanotech Roundup: Latest National Nanotechnology Initiative Strategic Plan Released for Comment - FDA Law Blog

FDA Law Blog: Nanotech Roundup: Latest National Nanotechnology Initiative Strategic Plan Released for Comment; NYAS Nanomedicine Conference Summary:

"The draft plan lays out the NNI’s goals and objectives, which remain largely unchanged from 2011 (see here). As with the 2011 Plan, the draft 2014 Plan includes a description of FDA’s NNI-related activities. Those activities continue to be primarily focused on the goal of supporting responsible development of nanotechnology. However, the 2014 Plan more explicitly recognizes the potential impact of nanotechnology on the status of FDA-regulated products:" . . .

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GMP Training Recommended: The Qualstar Simulation

Updated June 12, 2025

The live onsite course is no longer offered.

You might also be interested in online cGMP training courses offered by SkillsPlus International Inc.

---  the original post follows below  ---

Qualstar - A CGMP Simulation:

Designed to teach and to change the culture of companies, so that a focus on quality and compliance is achieved. This competitive simulation is an eye-opener for participant and executive staff observers alike.

Issues addressed in this exciting simulation:
1. Documentation problems
2. Procedures not being followed
3. Change control not practiced
4. QA not consulted on deviations

If this describes some of your issues, then you need to experience Qualstar!

Follow this link to learn more about Qualstar - A cGMP Simulation (a GMP training course)

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GMP Master Training Plans - Free Tips (Video)

Watch this video for free tips on GXP, QSR, and GMP Master Training Plans.

 

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FDA - CBER Releases Strategic Plan for 2012-2016

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Just released, the FDA CBER Strategic Plan for Regulatory Science and Research

CBER Releases Strategic Plan for 2012-2016 Period - RAPS - News - Article View:

"CBER’s plan outlines six core strategic goals it says will guide it through the next five years:

1. Increase the nation’s preparedness to address threats as a result of terrorism, pandemic influenza and emerging infectious diseases
2. Improve global public health through international collaboration including research and information sharing
3. Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
4. Ensure the safety of biological products
5. Advance regulatory science and research
6. Manage for organizational excellence and accountability"

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FDA Hurricane Preparedness Checklist

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Updated March 25, 2021

Hurricane season is coming soon, so be prepared.

According to the FDA, "The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages."

Hurricane Safety Resources - FDA.gov

The FDA breaks down preparations into these categories:

Food | Water | Pets | Drugs Exposed to Water | Insulin Storage/Switching | Medical Devices | Vaccines, Blood, Biologics | Find more information

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Tell Stories . . . - Free GMP Training Tip

GMP Labeling's Spring 2011 Newsletter is a good read:

Using Stories, Anecdotes, and Metaphors to Make your GMP Training Come Alive (pdf) - By David C. Markovitz

Lots of good ideas!

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The Adult Learner, Sixth Edition: The Definitive Classic in Adult Education and Human Resource Development

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FDA Regulated Businesses - Will you be compliant with the new FTC rule?

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If you're in the FDA regulated industries, you might want to pay attention to the FTC's new rule according to this Casetext post, August 1, 2009 - FTC’s New Identity Theft Rule Probably Requires You To Comply. In a nutshell, Koustas & Fleder say:

Given the apparent reluctance of the FTC to create exemptions from this regulation, most companies regulated by FDA must determine if the Rule applies to them. If the answer is yes, there is an August 1, 2009 deadline fast approaching to develop and implement a compliance plan. Failure to comply may subject the entity to administrative enforcement action by FTC as well as civil liability to consumers.

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FDA Must Consider Dropping Age Limit For Morning After Pill

The FDA let politics cloud its judgment when it denied teenage girls over-the-counter access to the Plan B morning-after pill, a federal judge said Monday as he ordered the FDA to let 17-year-olds obtain the medication. The judge ruled the agency had improperly bowed to political pressure from the Bush Administration when it set 18 as the age limit in 2006. U.S. District Judge Edward R. Korman in New York instructed the agency to make Plan B available to 17-year-olds within 30 days and to review whether to make the emergency contraceptive available to all ages without a doctor's order, reports this Washington Post news article, "FDA Ordered to Rethink Age Restriction for Plan B - Judge Says Politics Influenced Policy on the Contraceptive." What a polarizing firestorm this is going to create! What do you think?! 

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FDA Quality by Design - QbD - Executive Guide (pdf)

According to Cerulean Associates' Why Quality by Design? - An Executive's Guide to the FDA's Quality by Design (pdf), "Quality by Design is one of the most misunderstood and misused tools available to biopharmaceutical and medical device executives." The guide is easily understood and closes by driving to a 7-step QbD start-up plan. According to the guide, "the best way to assess how to implement QbD in your organization without making the same mistakes that other companies have made is to utilize a simple 7 step process."

Here's to hoping you enjoy and find this guide a good read, as I found it.

Related Posts:
Quality by Design (QbD) For Analytical Methods (video)

#FDA #GMP #training #cGMP

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FDA Draft Guidance On Good Importer Practices

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Updated October 6, 2022

Several links in the original post broke.

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Draft Guidance for Industry on Good Importer Practices; Availability - Federal Register

---  the original post follows below  ---

A group of federal agencies issued a draft guidance for industry on Good Importer Practices, with the intent to help importers ensure their products are safe and comply with U.S. requirements, FDA Guidance for Industry – Good Importer Practices.

The guidance is designed to anticipate potential sources of product hazards and offer preventive controls that firms can implement to mitigate such hazards and help ensure imported products are safe and compliant with regulations. The draft is organized under 4 guiding principles . . .

1. Establishing a product safety management program
2. Knowing the product and applicable U.S. requirements
3. Verifying product and company compliance with U.S. requirements throughout the supply chain and product life cycle
4. Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements

The draft guidance also recommends that:

• importers consider instituting practices to identify and minimize risks associated with imported products
• in general, importers should know the producer of the foreign products they purchase and any other manufacturers with which they do business, such as consolidators, trading companies, and distributors
• importers understand the products that they import and the vulnerabilities associated with these products
• importers understand the hazards that may arise during the product life cycle, including all stages of production, and ensure proper control and monitoring of these hazards

The agencies are issuing this draft guidance to implement recommendations outlined in the “Action Plan for Import Safety: A Roadmap for Continual Improvement,” issued by the Interagency Working Group on Import Safety, and to help foster a consistent approach by federal agencies and importers in ensuring the safety of products brought into the United States.

Related Posts: FDA Struggles To Keep Products From Foreign Sources Safe FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants

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