FDA Finalizes 2009 Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages - FDA Law Blog

FDA Law Blog: FDA Finalizes 2009 Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages:

"Compared to the 2009 draft guidance, the final guidance “Distinguishing Liquid Dietary Supplements from Beverages” provides considerably more information, including specific examples, on the factors FDA considers when determining whether the product is a conventional food or a dietary supplement.  As mentioned in the draft guidance, FDA considers labeling and advertising, product name, product packaging, serving size and recommended daily intake, directions for use, marketing practices and composition.  Where the draft guidance merely listed these factors, the final guidance discusses each factor and provides specific examples."

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The two new guidances:
Distinguishing Liquid Dietary Supplements from Beverages (PDF)
Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplement (PDF)

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Mobile Medical Applications: Guidance Finalized - FDA Law Blog

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FDA Law Blog: Mobile Medical Applications: A Thoughtful Guidance Is Finalized:

"The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from 29 to 43 pages. Most of the additional pages are appendices with examples and other supplementary information. This guidance is sensible and well written."

Follow this link to the Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF)

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FDA Draft Guidance Summarized: Delaying, Denying, Limiting, or Refusing a Drug Inspection

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Updated November 4, 2020

Some the links broke in the original post below.

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FDA Issues Draft Guidance on Definition of Denying, Delaying, Limiting or Refusing to Permit Inspection - The National Law Review

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA.gov (PDF)

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Facility Inspection Guidance Issued by FDA: Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA Lawyers Blog:

" . . . in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as adulterated a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection". (emphasis added)"

Read the draft guidance:
FDA - Draft Guidance for Industry - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF)

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GAO Makes Dietary Supplements AERs Recommendations to FDA

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U.S. GAO - Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products:

GAO recommends, among other things, that FDA explore options to obtain poison center data, if determined to be useful; collect information on how it uses AERs; provide more information to the public about AERs; and establish a time frame to finalize guidance related to GAO's 2009 recommendations. FDA generally concurred with each of GAO's recommendations.

Read the full GAO Report (PDF):
DIETARY SUPPLEMENTS - FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products

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FDA issues first social media rules for drug companies

amednews: FDA issues first social media rules for drug companies : Jan. 25, 2012 ... American Medical News:

"The Food and Drug Administration is giving pharmaceutical companies some rules for how they interact with consumers on social media. But the companies say they need a lot more clarification from the FDA before they're comfortable getting back online again. 

The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format."

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Read this draft guidance:
FDA - Guidance for Industry - Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF)

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Related articles

• Should Mobile Medical Apps Require FDA Approval? (drughealth.blogspot.com)

New FDA Guidance - Physical-Chemical Identifiers for Anticounterfeiting

This just recently published by the FDA:

FDA Guidances (Drugs); Newly Added Guidance Documents:

Chemistry, Manufacturing, and Controls (CMC): Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 74KB - Final Guidance 10/11/11)

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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!

You might also be interested in:
The Adult Learner, Sixth Edition: The Definitive Classic in Adult Education and Human Resource Development

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GMP Training - Tack It Onto Employee Safety Training

Updated September 6, 2025

Sadly, the original pdf link broke.

---  the original post follows below  ---

This FDA GMP training idea comes from David C. Markovitz in a training tip sheet entitled, GMP and Safety - Employee Safety and Customer Safety (pdf).

Here are my takeaways:

1. Take advantage of a captive audience by delivering GMP training to staff attending regularly scheduled safety meetings.
2. Start with employee safety and end with customer safety (GMP).

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FDA Orange Book - New - Updated For 2011

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


You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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There's been a lot of interest in the FDA's Orange Book by readers. Therefore, I'm pushing this information out to folks, so that they're aware.

It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.

If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

Happy hunting!

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FDA Orange Book 2011 - It Just Arrived!

Updated April 16, 2019:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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I've been watching and waiting for this to be released.

It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.

If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

Happy hunting!

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Brand New! FDA 2013 Orange Book 33rd Edition (pdf)

Updated March 3, 2020:

It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

New! - The 2010 FDA Approved Drug Products with Therapeutic Equivalence Evaluations 30th Edition (also known as the Orange Book).

Complete! - This FDA Orange Book 30th Edition is current through December 31, 2009.

Learn more about the Orange Book on the FDA website - Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).

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Looking Ahead to Pharma 2010 - Through the IBM innovation lens

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2010 is approaching fast. This is the time of year I start watching out for crystal ball predictions of what's in store for us. For example, check out IBM's vision for 2010, Pharma 2010: The Threshold of Innovation (pdf). 

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Cheerios Aside . . . FDA Gives Guidance On OTC Labels (pdf)

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Updated April 21, 2020

The link broke in the original post.

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FDA Guidance for Industry - Labeling OTC Human Drug Products — Questions and
Answers (PDF)  found on this FDA webpage  Labeling OTC Human Drug Products -- Questions and Answers

- - -  original post follows below  - - -

OK, now that we can chuckle about the Cheerios label fiasco, here's the scoop on what should go on OTC labels, "FDA Guidance for Industry - Labeling OTC Human Drug Products (PDF)"

In a nutshell, the Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand the new over-the-counter (OTC) labeling requirements set forth in 21 CFR 201.66 and prepare new labeling.

If you're new to this arena, you'll find this a real eye opener. The FDA even regulates things down to the detail of what size font you need to use, and more!

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New Guidelines Released for HIV Opportunistic Infections

The first complete update in five years of the U.S. guidelines for preventing and treating HIV-associated opportunistic infections has been released by the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) and Prevention in cooperation with the HIV Medicine Association of the Infectious Diseases Society of America (IDSA). The new Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents apply state-of-the-art science and medicine to 29 infectious diseases of concern. More than 140 medical experts contributed their knowledge to this edition of the guidelines, released on April 10. These new guidelines can be viewed in either html or pdf formats: Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (html) or Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (pdf) 

Related Posts: CDC Adopts 2 New HIV Intervention Approaches HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword HHS Updates HIV Treatment Guidelines (free pdf) 

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FDA - Focus On Opioid Manufacturer REMS FDAAA

Updated September 15, 2016

The original post didn't age well (broken links).

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Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids (FDA.gov)

- -  original post follows below  - -

If you're involved in or follow opioid manufacturing, you'll want to follow the FDA's focus on manufacturers of certain opioid drug products. FDA indicates that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks. You can expect to hear more about this over the next several months from the FDA.

More FDA Information About This Topic:
Transcript for FDA's Media Briefing on the Safe Use of Opioids
February 9, 2009 [pdf 52 KF] Audio [5.09 MB MP3]
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs

Previous Posts:
Opiates Can Kill Kids!

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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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Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)

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The FDA and medical device industry just got a wake-up call. Seems like this GAO report suggests greater rigor is needed in the premarket review process, MEDICAL DEVICES - FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. In any event, seems like this industry sector can expect potentially more rigorous regulation in the future . . . Bottomline, the reports states, "We are recommending that the Secretary of Health and Human Services direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process." From your perspective, would more stringent regulation be a good thing? 

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