8th Circuit Issues Decision Significant For All Executives Of FDA-Regulated Businesses - Consumer Protection - U.S. - mondaq.com

Read the full article: Eighth Circuit Issues Decision Significant For All Executives Of FDA-Regulated Businesses - Consumer Protection - United States - mondaq.com:

"Judges Murphy and Gruender explained, RCO liability bears on the blameworthiness of a corporate officer who failed to prevent or remedy the condition at issue. And any executive operating in the highly regulated world of food and drugs, where widespread harm can be the outcome of corporate negligence, has a “heightened degree of foresight and care.”"

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RCO = responsible corporate officer

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FDA Announces Inspection Procedure Change for 503A Compounders | Frier Levitt - Attorneys at LawFrier Levitt – Attorneys at Law

Read the full article: FDA Announces Inspection Procedure Change for 503A Compounders | Frier Levitt - Attorneys at LawFrier Levitt – Attorneys at Law:

"Effective August 1, 2016, FDA investigators now will make a preliminary assessment regarding a compounder’s compliance with conditions of section 503A and will not include observations that represent deviations solely from CGMP requirements unless the investigator’s assessment is that the compound drugs do not qualify for the exemptions under section 503A."

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Read the details of the FDA Notice (PDF)

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FDA to Drug Compounders: Inspection Changes Coming in August | RAPS

• Recommended FDA cGMP online training courses, classes, and programs sold by SkillsPlus International Inc.

Updated October 8, 2022

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Human Drug Compounding - FDA.gov

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Read the full article: FDA to Drug Compounders: Inspection Changes Coming in August | RAPS:

"For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators will make a preliminary assessment of whether such entities are compounding their human drugs in accordance with certain conditions of section 503A before closing the inspection.”"

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Read the details of the FDA Notice (PDF)

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Technical Considerations for Additive Manufactured Devices - FDA.gov

Guidance Documents (Medical Devices and Radiation-Emitting Products) > Recent Draft Medical Device Guidance Documents - FDA.gov:

"Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff" (PDF)

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Priorities – Teamwork to Achieve Common Goals | FDA Voice

Read Dr. Califf's Priorities – Teamwork to Achieve Common Goals:

"With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work for the nation and its citizens. During my vetting process I received hundreds of emails and had almost as many conversations with a large and diverse group of stakeholders. Over the course of these discussions, a recurring theme emerged: namely, that setting priorities would be critical to success."

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Data Integrity and Compliance w/cGMP - FDA Newly Added Guidance Documents

Go to the FDA website: Guidances (Drugs) > Newly Added Guidance Documents - FDA.gov:

Read this newly posted FDA guidance:
"Pharmaceutical Quality/Manufacturing Standards (CGMP) - Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 120KB) - Draft Guidance -  04/14/16"

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FDA Approved 3D Printed Drug Available In The US - Forbes

Read the full article: FDA Approved 3D Printed Drug Available In The US - Forbes:

"To create the 3D printed Spritam, all the elements are assembled layer-by-layer without compression or traditional molding techniques. Thin layers of powdered medication are then repeatedly spread on top of one another, as patterns of liquid droplets are printed onto selected regions of each powder layer. Interactions between the powder and liquid bond the materials together at a microscopic level."

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Wednesday: FDA commissioner | TheHill

• Respected FDA CGMP online training courses and programs by SkillsPlus Intl. Inc.

Read the full post:  Wednesday: FDA commissioner | TheHill:

"The Senate will take a final vote Wednesday on President Obama's nominee to lead the Food and Drug Administration.

The vote on Robert Califf's nomination to be the next FDA commissioner comes after senators overwhelmingly agreed to end debate on the nomination Monday in a 80-6 procedural vote. "

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Robert Califf Senate vote could clear path to top FDA job - STAT News

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Read the full article: Robert Califf Senate vote could clear path to top FDA job - STAT News:

"In a move designed to circumvent opposition to Califf, who was nominated in September, Senate Majority Leader Mitch McConnell has scheduled a procedural vote for Monday afternoon. If Califf wins the support of at least 60 senators in that vote, he would move on to a final confirmation vote — likely Tuesday — and his Senate opponents would lose their leverage to stop him."

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Major shift ahead in how FDA regulates drug quality: PwC

• Recommended FDA cGMP online training programs and courses by SkillsPlus Intl Inc.

Updated June 27, 2022

The link to the original source article broke.

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FDA Drug Quality Report - Major shift ahead in how FDA regulates drug quality: PwC:

"Parts of the pharmaceutical industry continue to struggle with drug quality. A major shift in the way the FDA oversees drug quality could pose new challenges for companies with inadequate control over their manufacturing facilities and supply chains."

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Read the PwC report:
Major shift ahead in how FDA regulates drug quality (PDF)

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