FDA Enforcement

Since 2021, the Pharma Manufacturing World Summit has gathered SVPs and VPs of Manufacturing, Quality, Supply Chain, Technical Operations Executives, and other industry professionals. These

In the evolving landscape of pharmaceutical regulation, the recent GDUFA III changes introduced by the FDA promise to enhance the submission and amendment process for

In session 4 of our Executive GxP Training program, Teresa Gorecki discusses understanding and managing the regulatory compliance risks to your business​. The two provide

The New 15% Rule The Components of the 15% RuleSystemsConsultantsCultureTimeFinal Thoughts on the Cost of a Warning LetterContact Us The New 15% Rule  Unfortunately, Warning Letters

In Teresa Gorecki's second session of Executive-level GxP training, the two reviewed Regulatory Compliance Fundamentals for Early-Stage Development​, emphasizing the importance of data integrity. Evolving

To navigate FDA warning letters amidst this complex landscape of regulations can often feel overwhelming. With over 3,300 warning letters issued by the FDA since

In the ever-evolving landscape of pharmaceuticals, innovation is not just a buzzword but a critical driver of progress. Recently, the FDA introduced a draft guidance

In this 4 part series, we are talking through GxP Best practices This article reviews the key highlights from Teresa Gorecki's Executive GxP training, Session

In the realm of clinical research oversight, adherence to regulatory standards is not merely a recommendation but a fundamental obligation. Recently, a significant development underscores

The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of drugs and devices. One of the key

Hello again, everyone. Welcome to another episode of Executive Platforms' Blueprint Podcast Series. I'm Geoff Micks, Head of Content and Research. Today, Teresa Gorecki from

Maintaining a regulatory compliance strategy is crucial for any company's sustainability and success in a rapidly evolving regulatory environment. When faced with substantial challenges, Compliance

The U.S. Food and Drug Administration (FDA) has issued new guidance detailing how it will assign goal dates for abbreviated new drug applications (ANDAs) based

Based on my recent discussions with clients and industry stakeholders, the consequences of the Supreme Court's recent Loper Bright v. Raimondo decision have become significant

Our practice lead, Teresa Gorecki, recently shared her LinkedIn article that addresses new medical device regulation changes with a recent FDA rule on medical device

The U.S. Food and Drug Administration (FDA) has introduced industry guidance that outlines the Platform Technology Designation Program, designed to bring efficiencies to drug development,

In a new development for global pharmaceutical regulation, the FDA and the European Medicines Agency (EMA) recently collaborated for the first time on quality assessments

We enjoyed our very own Teresa Gorecki, Practice Lead at Compliance Architects, speaking with Geoff Mix, Head of Content and Research for Executive Platforms, when

There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But

In today’s pharmaceutical manufacturing landscape, trust is paramount. Patients rely on drug manufacturers' integrity to provide safe and effective medications to manage complex, targeted health

In the dynamic landscape of biopharmaceuticals, ensuring the potency of cellular therapy or gene therapy (CGT) products is a paramount objective. This draft guidance serves

The FDA and other global regulators rely on data reviews during inspections to determine whether a pharmaceutical or medical device manufacturer operates within regulatory requirements and expectations. The credibility

Cell and gene therapies represent a new medical frontier, offering hope for treating rare, orphan, and challenging diseases. However, the journey from development to market

In the realm of quality and compliance within pharmaceuticals, biopharmaceuticals, and combination products, I’ve frequently been asked about the crucial steps to pass an FDA

The highly anticipated FDA Decision on the Harmonization of the Medical Device Quality System Regulations with ISO 31485-2016 has been released, marking a significant development

Attention life science quality and compliance professionals. Mark your calendars for this Thursday, August 18th at 2PM ET! Our colleague Teresa Gorecki is presenting with four

Risk is still an important issue, and the fundamental premise is that there is so much to do. With this important issue and ever-changing landscape,

Well-drafted, easy-to-understand quality records are crucial to helping pharmaceutical and medical device manufacturers navigate FDA inspection obstacles. The FDA relies heavily on information presented in

FDA inspection risk management is an essential activity for regulatory compliance within pharmaceutical and medical device companies.  While it is often challenging for medical product

Important DRAFT FDA Guidance issued today (dated 2/19/19 however) regarding "non-binding feedback" after FDA inspections of certain medical device establishments. Navigating FDA Guidance on Public

On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory guidance for agency practice by

On Thursday, December 7, Deputy Assistant US Attorney General Ethan P. Davis, US Department of Justice, Consumer Protection Branch, gave a speech at the Food

Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a

The election of Donald Trump as President-Elect of the United States was, and continues to be, a watershed moment in the 200+ year American experiment.  

The following FDA live review inspection information was included in our July email newsletter. There are many training sessions conducted each year by GMP Training

Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond 2015 is certainly ending with a bang.    As many of us industry insiders have

Early December is one of my favorite times of year. Coming off of Thanksgiving and looking forward to the end-of-year holidays, it’s when I get

I just posted a response on LinkedIn to a recent LinkedIn post by John R. Fleder  (from his firm's excellent FDALawBlog) surrounding FDA inspection authority

The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections,

The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning

If you have any role within an FDA-regulated company, it is likely you are aware that the FDA has been much more focused on FDA

The new FDA Inspections Database is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement

This is an UPDATE to a post from May 2010.Please click this link for the original post. IPhone UpdateDownloading FDA GMP/ QSR EbooksContact Us IPhone

Join the Center for Business Intelligence for a one-hour, information-packed webinar on managing FDA inspections from a more aggressive FDA.   Now that pharmaceutical, medical device, dietary

I’m struggling to find an answer to the following question:   If you were the owner of a company, how much would you spend, year over

The following transcript is taken from Business Intelligence Solutions Interview that talks about FDA Inspection Readiness. with Jack Garvey What are the biggest issues currently

A review of FDA enforcement news over the last year should clearly demonstrate an important shift in approach by the FDA that the “cop” side of

If you are reading this now, you are probably in the middle of an enforcement crisis.   Responding to an FDA-483, Warning Letter, or in some

Byline 1/19/2010, Legal TimesDOJ Undercover Sting Nets 22 in Large Scale Foreign Corrupt Practices Act Case If you are working in a senior legal, compliance