While most of us old timers grew up with Therapeutic Equivalence (TE) after the passage of Hatch-Waxman, the newly released draft guidance on TE (here) should be a good primer or refresher for most interested parties. There may also be some things you did not know, like how a 505(b)(2) application can request a TE […]
The dietary supplement market is notorious for issues associated with the inclusion of not-permitted ingredients in marketed supplements. Kratom is a recent poster child for this issue, but the erectile disfunction and weight loss markets both seem to have extraordinarily bad compliance and enforcement histories. These two disease states comprise the lion’s share of Warning […]
July had some fireworks early in the month, and when the smoke cleared on July 15th, the OGD reported twenty‑nine full‑approval actions and seven tentative‑approval actions (thirty‑six in total). If this pace continues, the OGD should surpass seventy total approval actions again this month. For the nine months already officially in the books, six of […]
With the issuance of draft ICH Quality Guideline ICH Q14 on Analytical Procedure Development (here) and revision of ICH Q2(R2) Guideline on Validation of Analytical Procedures (here), along with the issuance of USP <1220> Analytical Procedure Lifecycle, perhaps it may be time to revisit USP <1058> Analytical Instrument Qualification (AIQ). USP <1058> is a critical chapter providing key guidance on […]
“At the end of a wrench, is a patient.” The tragic events that happened twelve years ago aboard the Deep Water Horizon (yes, the one that the movie was based on) reinforced a sacred rule – accountability cannot be outsourced. For those who are not aware, of the approximately 126 personnel on board, only 7 […]
Yesterday, the FDA published a web page entitled, Mitigating Risks of Compounded Drugs Through Surveillance (here) which provides an overview of FDA’s Compounding Incidents Program. It discusses how the program works in evaluating reports of adverse events and a broad range of drug product quality complaints and what the outcomes can occur based on the […]
In an article titled “A Bipartisan Case Against US FDA User Fees?” published in the Pink Sheet on July 11, 2022, Michael McCaughan discusses two of the no votes from senators on reauthorization of the user fee program. McCaughan writes that Senators Richard Burr and Bernie Sanders “expressed concern that the increasing fees contribute to […]
In an earlier post (here), we projected the June approval number to be 52 full approval actions and 19 tentative approval actions. This morning the FDA published its official approval actions as well as other metrics (here) and our projections were spot on. The total of 71 approval actions (52 + 19) were exactly what […]
(Westbury, NY – July 11, 2022) – Frances Zipp, President and CEO of Lachman Consultant Services, Inc. (Lachman Consultants), a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, announced today that CAPT Martin H. Shimer, II joined the firm as Executive Director, Regulatory, effective July 11, 2022. In this […]
When we did our peek at the June Approval numbers mid-month (here), we predicted that June would be a good month and, at the time, indicated that there would likely be approval actions somewhere in the mid-60s. Well, OGD put the push on, and they actually broke the 70 barrier with 71 total approval actions […]
