Senate Confirms Scott Gottlieb to Head F.D.A. - The New York Times

Read the full article: Senate Confirms Scott Gottlieb to Head F.D.A. - The New York Times:

"The Senate voted 57 to 42 on Tuesday to confirm Dr. Scott Gottlieb as commissioner of the Food and Drug Administration, where he will be responsible for regulating drug companies to which he has had close ties in recent years."

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FDA > Drug Supply Chain Integrity > Verify Wholesale Drug Distributor Licenses

• Buy California Designated Representative Training:
     Wholesaler Course | 3PL Course | Reverse Distributor Course

Follow the link below to see a list of the U.S. state agencies responsible for drug wholesaler licensing. The list is organized by: State, Agency Name, and Website Link or Contact Info.

Drug Supply Chain Integrity > Verify Wholesale Drug Distributor Licenses - FDA:

"U.S. State Agencies Responsible for Licensing Wholesale Prescription Drug Distributors" ...

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You might also be interested in drug wholesaler-related training & resources:

• California Designated Representative online training by SkillsPlus Intl Inc 
• Florida Certified Designated Representative (CDR) online exam prep course
• The Designated Representative Institute

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FDA - Product Requirements, Marketing & Labeling > Extending Authorities to Additional Tobacco Products

• FDA GMP QSR cGMP Training - popular online training courses taught by SkillsPlus Intl Inc.

Updated July 1, 2025

The original link broke.

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FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements

Guidance for Industry: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-deems-certain-tobacco-products-subject-fda-authority-sales-and-distribution-restrictions-and

- - -  original post follows below  - - -

Product Requirements, Marketing & Labeling > Extending Authorities to Additional Tobacco Products - FDA:

"Currently FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.

Once the proposed rule becomes final, FDA will be able to use powerful regulatory tools, such as age restrictions and rigorous scientific review of new tobacco products and claims to  reduce tobacco-related disease and death."

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Root Cause Investigations Workshop - GMP Training

ROOT CAUSE INVESTIGATIONS WORKSHOP
#FDA #GMP #QSR #cGMP #training #course #class

Learn how to dig deeper and discover what's really below the surface. In this course, students apply root cause analysis tools to real in-plant deviations.

Learn more: http://www.skillsplusinc.com/root_cause.htm

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Medical device firms growing in South Florida

Medical device firms growing in South Florida - South Florida Sun-Sentinel.com:

"Florida is the fastest-growing state in creating new biotech companies and ranks second in medical device firms, according to global research firm Battelle. The southeastern region of the state, which includes Broward and Palm Beach counties, has the largest number of bioscience companies in Florida, as tracked by a University of Florida life science database.

Venture capitalists and investors are taking notice, listening to pitches at last week's BioFlorida conference from local firms seeking partners and funding. But there are many hurdles to success.

For medical devices, those challenges include ongoing financing of research, completing successful clinical trials, paying for expensive regulatory approvals, and ultimately getting hospitals and doctors to use the products."

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Live Onsite GMP Training - Essentials for Pharmaceutical Manufacturers

Updated November 8, 2022

The links in the original post broke.

You might also be interested in:

FDA cGMP online programs, courses, and classes offered by SkillsPlus International Inc.

---  the original post follows below  ---

Here's one of our popular onsite cGMP training classes:
   Essentials for Pharmaceutical Manufacturers - cGMP training by SkillsPlus Intl Inc.

This live class can be taught at the client site location of your choice.

This class teaches employees how to identify the essential elements of CGMP for beginning work in the pharmaceutical and biotech industries.

Upon completion of this class, students will be able to:

1. State the historical development of CGMP regulations. 
2. Explain the role and function of standard operating procedures. 
3. Describe the personal role for contamination control. 
4. Identify the sources of contamination. 
5. List the common CGMP documentation practices. 
6. Explain material controls. 
7. State the common practices of production and process controls. 
8. Explain the importance of an adequate, appropriate, and sufficient building design. 
9. State the requirements of equipment design and construction. 
10. List the requirements for building, and equipment cleaning and maintenance. 
11. Explain the role of quality assurance. 
12. Explain the role of quality control.

Learn more about this class:
Essentials for Pharmaceutical Manufacturers - cGMP training by SkillsPlus Intl Inc.

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FDA cGMP & QSR Online Training Courses by SkillsPlus Intl Inc.

Happy New Year!

Now that the new year is here, don't delay your training planning.

We've got an exciting, energizing, and engaging slate of cGMP and QSR training courses and classes to offer you.

Check out our new:
FDA cMP QSR GMP online training courses by SkillsPlus International Inc.

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