Retail Sales of Tobacco Products - FDA.gov

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Read the full article:  Retail Sales of Tobacco Products - FDA.gov

"Note: On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available."

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FDA GMP QSR cGMP online training classes by SkillsPlus International Inc.

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Our Most Popular FDA GMP Online Training Courses

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• Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

The most popular GMP online training classes by SkillsPlus Intl Inc.

GMP Trainer Awareness, Certification, & Master Trainer Course

Root Cause Analysis and Investigation Report Writing 

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It's official: New FDA Commissioner Hahn wins Senate confirmation - FiercePharma

• FDA GMP cGMP online training courses by SkillsPlus International Inc.

Read the full article:  It's official: New FDA Commissioner Hahn wins Senate confirmation - FiercePharma

According to the article:

"The FDA has been plenty busy without an official commissioner since former head Scott Gottlieb stepped down earlier this year, but now it has a new chief to take on the job.

Stephen Hahn, formerly chief medical officer of the University of Texas MD Anderson Cancer Center, secured confirmation from the Senate Thursday in a 72-18 vote, according to reports. He takes over the agency's sprawling brief, which covers pharmaceuticals, food safety, medical devices and tobacco."

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The Largest Selection Of Board-Approved California Designated Representative Online Training Programs

• Three (3) different and unique California Designated Representative online training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit. Purchase now to take a course for:  Wholesalers | 3PL | Reverse Distributors.

The largest selection of Board-approved California Designated Representative online training classes!

Three (3) different and unique California Designated Representative online training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.

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California HMDR Exemptee Online Training Certification Class

• California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. For home medical device retailers. $525 per student. No extra fees to retake quizzes..  Enroll now >> California HMDR Exemptee Online Training Class

If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate accepted by the CDPH - include it in your license application.

California requires home medical device retailers (HMDR) to retain an on-site Exemptee  to conduct their business.  The Exemptee must be physically present during all hours of operation. This course is recommended by the California Department of Public Health as it meets the training requirements specified for HMDR Exemptee license applicants, and covers:

California HMDR Exemptee Training Class

• State and Federal laws relating to the distribution of dangerous drugs and dangerous devices
• State and Federal laws relating to the distribution of controlled substances
• Knowledge and understanding of quality control systems
• The United States Pharmacopoeia standards relating to the safe storage and handling of drugs
• The safe storage and handling of home medical devices
• Prescription terminology, abbreviations, and format

To meet the requirements, we offer a web-based, self-study class and the final exam for this certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed. Nearly 10,000 students have taken our state license-related training courses.

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California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. For home medical device retailers.

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FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims - FDA.gov

• FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

Read the full news release:  FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety - FDA.gov

Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

According to the news release:

"... the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases."  ... 

"The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food."

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Report On The State Of Pharmaceutical Quality - FDA.gov

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Center For Drug Evaluation And Research - Office Of Pharmaceutical Quality

Report On The State Of Pharmaceutical Quality - FDA.gov

Assuring quality medicines are available for the American public


The report is a good read.  It's data-rich, and provides a good overview.

This comes from the report's introduction:

"The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) monitors the quality of CDER-regulated drugs legally marketed in the U.S. A quality drug is consistently safe and effective, free of contamination and defects. Patients and consumers expect quality drugs with every dose they take. The ‘State of Pharmaceutical Quality’ is a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products."

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What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov

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Read the FDA article: What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov

According to the FDA article:

"The FDA is committed to sound, science-based policy. The FDA is raising these safety, marketing and labeling concerns with you now because we want you to know what we know. We hope that you will provide any data that you have to the public docket.

Today’s Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make smart choices about CBD products. Also, as the regulatory pathways are clarified we will take care to notify all stakeholders as quickly as possible.

More information is available at: FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers."

FDA kicks off review of CBD with 140 people scheduled to testify at first public hearing Friday - CNBC.com

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Read the full article:  FDA kicks off review of CBD with 140 people scheduled to testify at first public hearing Friday - CNBC.com

"The Food and Drug Administration will hear from CBD manufacturers, researchers, farmers, retailers and more on Friday as the agency holds its first public hearing looking at the sale of what’s being touted as a magical elixir that can treat everything from inflammation to epilepsy."

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SkillsPlus International Inc. Announces Online GMP e-Learning Courses

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Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

• In 8 one-hour segments learn what the experts know about the CGMPs for Pharmaceutical and Biotech manufacturing. 
• Learn more, and view the details about CGMP Training: A New Generation Series

Ask yourself these three questions:

1. Do you need to conduct CGMP Training on a limited budget? 
2. Do you want employees to learn the CGMPs from an expert using real examples? 
3. Do you need CGMP Training resources suitable for multiple levels of the organization?

If you answered YES to any of these three questions then you should take a look at the courses below:

• 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
• Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
• Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
• Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
• Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
• Plan to Production - Part F. Review the requirements for production process controls and validation.
• Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
• Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
• Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.

FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

FDA.gov Website Refresh - FDA.gov

• FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

Read the full announcement:  FDA.gov Website Refresh - FDA.gov

Images of the new FDA.org website

According to the announcement:

The goals for the improved FDA.gov include:

• Remodeled webpages that can be viewed on any internet-ready device
• Easier access to popular content
• Updated navigation based on data and audience behavior
• Easier to find FDA content in search results
• Better consistency of FDA content across web and social channels

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FDA & FTC Crack Down on CBD False Medical Claims - HealthcarePackaging.com

• FDA cGMP, QSR, and GMP Training Courses by SkillsPlus Intl Inc.

Read the full article:  FDA & FTC Crack Down on CBD False Medical Claims - HealthcarePackaging.com

"The FDA and FTC sent warning letters to three CBD companies making false claims about treating diseases like cancer and Alzheimer’s." 

"The letters claim the companies are falsely advertising the effectiveness of supplements to treat diseases including cancer, Alzheimer’s, fibromyalgia, and neuropsychiatric disorders. This marks the first time the FDA and FTC have issued a joint warning letter together."

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FDA Issues Guidance On Continuous Manufacturing

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Updated June 25, 2023

The original link broke.

You might also be interested in:

Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry - FDA.gov (PDF)

---  the original post follows below  ---

Quality Considerations for Continuous Manufacturing - Guidance for Industry

The guidance provides information regarding the FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER). The guidance describes several key quality considerations and provides recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small molecule, solid oral drug products that are produced via a continuous manufacturing process. FDA supports the development and implementation of continuous manufacturing for drug substances and all finished dosage forms where appropriate, including those submitted in NDAs, ANDAs, drug master files (DMFs), biologics license applications (BLAs), and nonapplication over-the-counter (OTC) products. Scientific principles described in the guidance may also be applicable to continuous manufacturing technologies used for these drugs. However, the guidance is not intended to provide recommendations specific to continuous manufacturing technologies used for biological products under a BLA.

Source:  Quality Considerations for Continuous Manufacturing - FDA Guidance for Industry (PDF)

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FDA Signals Strengthening Regulation of Dietary Supplements - FDA.gov

• cGMP Training and FDA Training Courses by SkillsPlus Intl Inc.

Read the full press announcement:  Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

Snippets from the FDA Commissioner's statement:

". . . we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.

One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.

As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies  whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer."

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