Blog - Lachman Consultant Services, Inc.

Efficiency in Drug Establishment Requirements for Certain Multiple Sites under a Common Legal Entity

By Bob Pollock Jul 10, 2026 Compliance Manufacturer Facility Registration and Listing Regulatory Affairs

FDA issued a proposed rule titled “Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments” to modernize drug manufacturer listing requirements for certain entities. The proposed rule would permit a hub-and-spoke model single listing to identify multiple manufacturing sites engaged in a distributed manufacturing model. Now do […]

Jul

CDMO Growth Creates Data Integrity Risks Across Company Boundaries

By Patrick Day Jul 09, 2026 ANDAs Biosimilars BLA Compliance IND NDA Supply chain

The pharmaceutical supply chain is no longer just a chain of physical materials, but rather a complex series of data, data-based decisions, and delegated responsibilities for that data. FDA’s CDER FY2024 Site Catalog reported 4,619 manufacturing sites globally, reflecting the broad scale of the regulated manufacturing network supporting the U.S. drug supply. Within that network, […]

Jul

HHS Unified Rule Agenda for 2026

By Bob Pollock Jul 08, 2026 ANDAs Biologics Biosimilars BLA Compounding Devices Dietary Supplements Labeling NDA Regulatory Affairs

The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]

Jul

D-Day Coming for the Use of Certain Peptides in Pharmacy Compounding

By Bob Pollock Jul 07, 2026 Compliance Compounding Regulatory Affairs

In a previous blog posted on April 16, 2026 (here), we discussed the announcement from FDA regarding an upcoming meeting of the Pharmacy Compounding Advisory Committee to be held on July 23-24, 2026, focused on the inclusion of some active ingredients on the permitted pharmacy compounding list. That post identified seven peptide active ingredients that […]

Jul

Are Your Analytical Method Validation Protocols Keeping Up with Evolution in Industry?

By Paul Mason, PhD. Jul 07, 2026 Compliance Methods validation Validation

Analytical method validation performed in industry is undergoing a significant transformation—and if your analytical method validation protocol templates haven’t evolved, now is the time to take a closer look. The United States Pharmacopeia (USP) has proposed a revision to USP <1225>, Validation of Analytical Procedures. This update brings the chapter into closer alignment with ICH Q2(R2) […]

Jul

Unofficial June 2026 Approval Actions

By Bob Pollock Jul 06, 2026 ANDAs Approvals Regulatory Affairs Statistics

June was a hot month for most of the East Coast, and it was a hot month for ANDA approval actions too (albeit but just a tad cooler than May’s numbers). OGD managed to issue 76 full approval actions and 17 tentative approval actions for a total of 93 approval actions in June. The 76 […]

Jun

Data Integrity in Device Submissions – Three Firms Zinged by FDA

By Bob Pollock Jun 30, 2026 Data Integrity Devices Regulatory Affairs

In a June 25, 2026 notice on data integrity in medical devices, the FDA takes note of “an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical […]

Jun

Big Generic First Approval – The Good News and the Bad News!

By Bob Pollock and Martin Shimer Jun 29, 2026 ANDAs Approvals Regulatory Affairs

The FDA approved the first generic of Baloxavir Marboxil tablets 40 mg and 80 mg for Norwich Pharmaceuticals Inc., on June 17, 2026. It is the generic equivalent of Genentech’s Xofulza approved for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 […]

Jun

One Adequate and Well-Controlled Study – Be Sure You Meet with the FDA!

By Bob Pollock Jun 25, 2026 Biologics BLA IND NDA

The new draft guidance “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products” (here) provides the industry with a foundation for providing one adequate and well-controlled study with appropriate confirmatory supporting data to satisfy the Agency’s requirement for demonstrating safety and efficacy. While this may, on its face, appear to be a boon […]

Jun

Official May 2026 ANDA Approvals, Receipts, and Other Metrics

By Bob Pollock Jun 24, 2026 ANDAs Approvals Generics OGD Regulatory Affairs Statistics

The OGD released its May 2026 Generic Drugs Program Monthly and Quarterly Activities Report (here) late Tuesday evening. In our blog covering unofficial May mid-month approval actions (here), we surmised that the final ANDA approval numbers would be significantly lower than the May numbers when the official metrics came out and we were right… they […]

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