Data Integrity

22
May

Two Chinese Testing Labs Come Under Serious FDA Scrutiny

Today, May 22, 2025, “[t]he U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid” (see the FDA announcement here).  The two labs receiving the so-called General Correspondence Letters are […]

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06
May
Shocked bearded Latin man wearing stylish eyeglasses, holding laptop, using computer with open mouth

Question About the Frequency of Unannounced Foreign Inspections, FDA Seems to Be Listening!

Today, the FDA announced the “Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities” (here), signaling that the Agency appears to be leveling the playing field between domestic and foreign facility inspections. According to the comments in the May 5, 2025 Regulatory Affairs Professionals Society (RAPS) Regulatory Focus article by Joanne S. Eglovitch (here), the “unannounced foreign […]

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16
Apr
Some More Interesting Tidbits from the Recent Generic Drug Forum - Lachman Blog

Some More Interesting Tidbits from the Recent Generic Drug Forum

The Generic Drug Forum was a two-day event held on April 8-9, 2025. This was one of the first public engagements that the Office of Generic Drugs (OGD) participated in since the current administration’s pause on FDA communications was announced in February 2025. There were many interesting sessions that presented an enormous amount of content. […]

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14
Apr
Do You Trust What Your Drug Applications are Saying - Lachman Blog

Do You Trust What Your Drug Applications are Saying?

Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust. Imagine […]

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25
Mar
Data Integrity and Annex 1 - Lachman Blog

Integrating QRM, Data Integrity and Annex 1

On October 26, 2020, a business plan was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) that eventually resulted in a holistic revision to ICH Q9, “Quality Risk Management,” the “R1” of the framework. The four areas of concern were identified as: High levels of subjectivity in risk assessments […]

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12
Mar
A stack of papers labeled fraudulent claims. Insurance fraud and legal investigation.

Fraud Continues in the Clinical Trial Arena – Sponsors Beware

Today, I read an article in Dickinson’s FDA Webview (here; subscription required) titled “Clinical Researchers Plead Guilty to Fraud” that has the following rather chilling opening line: “Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with their work on two clinical trials testing drugs […]

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13
Feb
Ensuring Data Integrity at Contract Laboratories Who is Accountable - Lachman Blog

Ensuring Data Integrity at Contract Laboratories: Who is Accountable?

Deflecting responsibility is a timeless tactic for the young. While it was easy to simply point the finger and say, “I didn’t do it, they did,” as children, this approach is not viable in the life-sciences industry when things go awry. In this sector, we can’t simply transfer our responsibilities without written agreements and clear […]

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04
Nov
Laptop Cartoon - Thinking

Cybersecurity and AI: Navigating the Digital Frontier

In an era of rapid technological breakthroughs, the incorporation of artificial intelligence (AI) into numerous industries is transforming the way in which we all work. AI has been shown to be a valuable tool for automating mundane processes and analyzing large datasets. However, as we embrace its potential, we must also address the cybersecurity threats […]

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