The Lachman Blog

29
Sep

Validation Still the Key to Success

The 16th annual WRIB (Workshop on Recent Issues of Bioanalysis) is being held in Atlanta, GA this week with approximately 800 attendees at the workshop.  The workshop which runs through Friday, is well represented by regulators from across globe, and industry (both from Pharma and CROs) with numerous discussions and topics for bioanalysis ranging from […]

Read More
28
Sep

Know Your Systems!

It is evident from reviewing recent health agency citations that the FDA expects that firms have a deep understanding of any systems that generate data/records and that this is reflected in the firm’s lifecycle management of those systems. What does that mean, in a practical sense? Well, a component of this understanding must extend to […]

Read More
28
Sep
Quality Agreements Image

Great Quality and Great Business Is Interdependence in Plain Sight?

If our supply chain was weak prior to the pandemic, this global event accelerated its failure.  These signals of weakness were laid bare during the pandemic  and identified in publications such as the 2019 report “Drug Shortages:  Root Causes and potential Solutions” (here).  Prior to the Covid PHE, focus on shortages was placed much more […]

Read More
27
Sep

Here We Go Again! Virginia Rep. McEachin Does Not Get It!

Congressman A. Donald McEachin (VA-04) comments “Today, [I] introduced the Updated Drug Labeling for Patient Safety Act, legislation to direct the Food and Drug Administration (FDA) to allow generic drug manufacturers to update their product labeling with safety-related information.” (see here). He notes that “[T]he Updated Drug Labeling for Patient Safety Act is commonsense legislation […]

Read More
26
Sep

Data Integrity Series: Episode 4

Episode #4 of our six-part Data Integrity video series focuses on Systems and Processes, two more essential elements for minimizing and eliminating data integrity issues. The video explains the four key points of Systems and Processes necessary for establishing a world-class data integrity program and the two primary controls that well-established Systems and Processes provide. […]

Read More
26
Sep

Sally Choe OGD Director Leaving!

According to Zachary Brennan’s story on Endpoints (here),  Sally Choe will be leaving OGD in two weeks coinciding with the end of GDUFA II and the beginning of GDUFA III.  The interim Director will be Susan Rosencrance “who’s currently director of the FDA’s Office of Lifecycle Products in the Office of Pharmaceutical Quality and has […]

Read More
23
Sep

Feedback from Industry on July 2022 Guidance Regarding TE Ratings for 505(b)(2) Products

I read a great article by Joanne S. Egolvitch in the RAPS Regulatory News this morning about elimination of Citizen Petitions for TE ratings for 505(b)(2) products (here).  The issue centers on the FDA’s (kind of wonky) requirement that 505(b)(2) applications with minor formulation changes requiring them to be submitted as an NDA also require […]

Read More
22
Sep

September 2022 Peek at Approval Actions

Based on a strong start to the month, the OGD has issued forty approval actions but only two tentative approvals based on information posted through September 20th.  Sorry that this mid‑month review was a bit late; with about two‑thirds of the month gone, I don’t expect to see another month like those we’ve seen lately.  […]

Read More
1 2 176