FDA.gov Website Refresh - FDA.gov

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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

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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.

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

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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

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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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FDA releases statement underlining their powers to manage a selection of cannabis products

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Read the entire press release:  FDA issues statement underlining their powers to manage a selection of cannabis products on FDA.gov

"Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. 

Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds."

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As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

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Read the full article:   As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

"Although most of the agency's employees weren't working over the weekend and on Monday and Tuesday because of federal holidays, FDA will furlough some 40 percent of its staff starting Wednesday. 

However, much of the agency's workforce will continue through the shutdown, with more than 10,000 FDA employees — nearly 60 percent — reporting to work, according to numbers released by the agency Friday."

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Data Integrity and Compliance With Drug CGMP Questions and Answers - FDA.gov

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Read the entire FDA guidance (pdf):  Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry - FDA.gov

"In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The underlying premise in §§ 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FD&C Act regarding safety, identity, strength, quality, and purity. Requirements with respect to data integrity in parts 211 and 212 include, among other things: . . . "

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FDA plans to use ISO 13485 for medical devices regulation - ISO.org

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Read the full news article: FDA plans to use ISO 13485 for medical devices regulation - ISO.org

"The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally. 

ISO/TC 210 warmly welcomes the FDA’s planned adoption. This ISO technical committee, responsible for the quality management and corresponding general aspects for medical devices, is run by ANSI, ISO’s member in the United States."

Learn more about the proposed rule:

• RIN: 0910-AH99 - Title: Harmonizing and Modernizing Regulation of Medical Device Quality Systems
• Follow the status of the proposed rule on FDA.org (enter "0910-AH99" in the Search box)

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RAPS Releases Results of Compensation Survey of Regulatory Professionals - RAPS.org

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Read the full news article:  RAPS Releases Results of Compensation Survey of Regulatory Professionals - RAPS.org

"RAPS today released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organizations have evolved."

Navigate to the report:   2018 Global Compensation & Scope of Practice Report for the Regulatory Profession


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FDA Released 3 DSCSA-Related Guidances - Healthcare Packaging

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       Wholesalers | 3PL | Reverse Distributors

Read the full article:   ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

According to the article, the FDA released the following guidances:

1. Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers Guidance for Industry (PDF)
2. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF)
3. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy (PDF)

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - Earn a training affidavit

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute