The Lachman Blog

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. […]

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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 […]

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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 […]

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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.  […]

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22
Sep

AAM 2022 Report on Generic and Biosim Savings for 2021

It’s no surprise that the use of generic drugs saves consumers and health plans big money.  Now, add the savings being achieved from biosimilars (expected to increase significantly over the next year or two) and the amount is almost staggering! The just-released report, which can be found here, provides details that support the findings that […]

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20
Sep

Remote Non-Inspection “Inspections”

Throughout the PDA-FDA Joint Regulatory Meeting that took place September 12-14, 2022 in Washington D.C., the subject of Remote Assessments (RA), also called Remote Interactive Evaluations (RIEs), was repeated over and over again in sessions.  This is not a new thing, as the Guidance for Industry (GFI), “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch […]

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15
Sep

It’s Elementary – FDA Guidance for Na, K, and P Labeling for Rx and OTC Products

Published a few days ago, the FDA draft guidance titled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (here) discusses the FDA’s thinking on the standardization, proper format, and necessary information for the contents of these elements in OTC and prescription drug labeling.  Right now, labeling for OTC products […]

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15
Sep

Changes Forced Upon FDA and Industry Highlighted at PDA FDA Joint Regulatory Conference

At the first in person PDA/FDA Joint Regulatory Conference since the pandemic began, (held September 12-14 in Washington, DC), it was almost impossible to escape the effect that the pandemic had on everyone attending the meeting, regardless of their affiliation. From the inevitable exclamation from presenters at the podium about how great it was to […]

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