FDA Releases Proposed Guidance On Combination Products

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Updated July 5, 2024:

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FDA - Combination Products Guidance Documents

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This Federal Register notice announces the FDA release of a proposed rule on combination products, Current Good Manufacturing Practice Requirements for Combination Products (pdf). According to the FDA Law Blog post, FDA Issues Proposed Rule on cGMPs for Combination Products:

The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.

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Series About Wine And Your Heart

I ran across this information packed and thought provoking series about wine and your heart. It consists of 3 parts:

• Part I: More than just Enjoyment!
• Part II: Preventing Heart Attacks
• Part III: To the Heart of the Matter

Ellen Mack, M.D., M.P.H., the author, says:

The first two parts (see Part 1 &Part 2) of the series Wine and your Heart examined some of the vast epidemiological and scientific evidence that moderate consumption of wine is associated with decreased cardiac mortality. Is this information being put to good use?

For me, this all means, drink a little to be healthy. Cheers!

Previous Posts: Men - Study Says Drink Wine and Live Longer Epidemiological Reasons To Drink Alcohol For Health Australian Wine Doctor Says Drink His Wine For Health

For Wine Lovers: Wine Lovers Dishwasher Magnet Champagne In The Freezer - Reminder Magnet Wine In The Freezer - Reminder Magnet (10 pack) Ask About Our Wines Magnet (10 pack) Return Home: http://drughealth.blogspot.com/ GMP Posters The Health, Drug, Prescription, and GMP Supersite Gift Store 

Upton Sinclair Belated Birthday - Inspired FDA Creation

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Updated April 20, 2024

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Upton Sinclair, Muckraking Journalist and Author of “The Jungle” - 2Day Sweet Search

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Happy Birthday, Upton Sinclair, Muckraking Journalist and Author of "The Jungle"

He was born on September 20, 1878.

Among his notable accomplishments, according to the article above:

. . . nothing Sinclair wrote ever eclipsed the fame of his exposé, “The Jungle.” The 1906 novel was intended to spotlight dangerous and unfair working conditions in turn-of-the-century meat factories. Instead, it inspired a generation of vegetarians and a host of new food safety regulations, including one that ultimately led to the creation of the Food and Drug Administration(FDA).

The Jungle - Upton Sinclair - Postcards (Pkg of 8)

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FDA Offers Warning Letter Close-Out Letter Program

According to the FDA's announcement, Warning Letter Close-Out Letter Program, the FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009. 

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Mesothelioma Awareness Day

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According to Mesothelioma Awareness Day Observed September 26 , "on September 26, 2009 those affected by the asbestos-related cancer mesothelioma and volunteers worldwide will help call attention to the rare cancer on national Mesothelioma Awareness Day. The Mesothelioma Applied Research Foundation, the non-profit organization that started the day in 2005, expects the day to be the most successful awareness day for the cancer since it was organized four years ago." 

Previous Posts: New Technique Might Help Diagnose Mesothelioma CDC Says Mesothelioma Deaths Increasing Reputable Mesothelioma Resources 

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Free FDA IND Education For Small Business on Oct 15 2009

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process, CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.

• Agenda (PDF - 64KB)
• Registration form (PDF - 20KB)

Date: October 15, 2009 Time: 8:00 a.m. - 5:00 p.m.

Send the registration form to CDERSmallBusiness@fda.hhs.gov. For more information contact Ron Wilson at 301-796-3177 or Brenda Stodart at 301-796-3102. There is no registration fee Space is limited to 225 participants. The FDA appreciates advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis. 

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FDA Says You Only Have 15 Days To Respond To Form 483

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Updated September 7, 2021

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You can still read about the topic here:

The Emergency Guide To FDA Warning Letters & FDA 483. How to handle inspectional observations and warning letters from the FDA. A White Paper by The FDA Group LLC.

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According to this PharmTech article, FDA Begins Enforcing Deadlines on Form 483 Responses, you have only 15 days to respond to a form 483. Be aware, this article states:

Now, however, FDA “will not ordinarily delay the issuance of a warning letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued,” according to an announcement in the Federal Register.

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10 Tips - How to Avoid FDA 483 and Warning Letters

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Updated February 15, 2021

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Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments - MasterControl

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It never hurts to review or re-review your policies and procedures. 

Check out this white paper, Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations. 

Previous Posts: 

• CAPA Problems - Most often cited 483 deficiency 
• More FDA 483 Resources - Comments and Pearls from Validation Online 
• FDA 483 Inspectional Observations - learn from these examples 

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New HIV Antibodies Hold Promise For Vaccines

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Scientists at the Scripps Research Institute report promising findings in their research report, Broad and Potent Neutralizing Antibodies from an African Donor Reveal a New HIV-1 Vaccine Target. According to this LA Times news article, Antibodies found that prevent HIV from causing severe AIDS, this means that they have isolated two so-called broadly neutralizing antibodies (bNAbs) that can block the action of many strains of HIV, the virus responsible for AIDS. Other bNAbs against HIV have been discovered before, but PG9 and PG16 are the first to be isolated in over 10 years from donors in developing countries, where most new HIV infections occur. Also, the previously identified bNAbs bind to spots on the virus that are hard to target with vaccines. These new antibodies, which are more potent than other antibodies described to date while maintaining great breadth, attach to a novel, and potentially more accessible site on HIV to facilitate vaccine design. 

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FDA Updates Warning Letters Web Page

The U.S. Food and Drug Administration has reorganized and updated the warning letters page in the Inspections, Compliance, Enforcement, and Criminal Investigations section of the FDA Web site. The changes on the Web page are as follows:

• Every Tuesday, the most recently issued warning letters now will be presented under Recently Posted with the date posted.
• Effective Sept. 1, the Close Out Date is now provided in the Warning Letters table and detailed information about the Warning Letters Close Out Program is provided.
• Additional changes include formatting and improved page navigation to help users understand what searching and browsing options are available.

The “Warning Letters” page can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm. The FDA will continue to look for ways to improve the “Warning Letters” webpage in the future.

Previous Posts: Food Industry Ramifications of the FDA Cheerios Warning Letter FDA Warning Letter - Space Shuttle Fruitcake

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30 FDA GMP Compliance Tips

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Updated September 1, 2020

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White paper: The 10 Golden Rules of GMP - Pharmout (PDF)

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I stumbled across this and thought you might make use of it too, 30 tips to bring you closer to GMP compliance - 30 common sense ways to avoid making the most frequent GMP errors. This is a well-written piece and reminder for the most basic and most important things to remember. It's a quick checklist of things you should already be doing. 

Previous Posts: 

FDA GMP - Tips on Penicillin Drugs
FDA - Preparation Tips For Meetings With The FDA
FDA GCP - Tips On Conducting non-US Studies
Avoid FDA 510k Medical Device Clearance Mistakes - 5 Free Tips
Medical Device Sponsors - FDA Trends and Tips To Avoid 483s
FDA 510(k) Free Tips And Pearls Of Wisdom
GLP Training Tips (free)
Free GMP Training Tips - Follow adult learning principles

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Tobacco Will Kill Millions Next Year

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This is a really sobering statistic, as reported in this MSNBC news article, Tobacco to kill 6 million next year, report says - 1 in 10 deaths globally is due to tobacco use, American Cancer Society says. The news article highlights key findings. I was particularly drawn to the interactive report found on the web, The Tobacco Atlas. Previous Posts:

• FDA Wants Your Input On Tobacco Regulation
• Smoking Is Too Expensive - It is time to quit
• e-Cigarettes In The News (video)

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Food Industry Ramifications of the FDA Cheerios Warning Letter

Sarah Sunday writes this excellent legal opinion explaining the background and ramifications of the FDA's warning letter to the makers of Cheerios, Is FDA Warning Letter An Ominous Signal To Food Industry? This is all about the FDA objecting to the statement that Cheerios can lower cholesterol levels. In a nutshell, she says:

"FDA's Warning Letter is a slap on the wrist in terms of the potential regulatory consequences. However, the letter could have a significant legitimizing effect on the pending California lawsuit, and in that way, could have costly implications for both General Mills and the food industry as a whole."

Previous Posts: And The Top 10 Food Stories Of 2008 Pet Food Sickened People - Did they eat it? . . . Time To Talk About Turkey Cooking and Food Safety FDA CFSAN - Food Safety and Nutrition Video Library (free) 

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