There has been turmoil in the world; everything seems to have gone crazy. It’s hard to find faith or even truth in our politicians. Laws have been broken and our democracy was almost broken. But, with the 2022 mid‑year election, we seem to have taken a step back from the precipice. In thinking about our […]
The 17th Annual FDA Inspections Summit kicked off with high energy by keynote speaker Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations Regulatory Affairs who presented on the FDA perspective on inspections. As the entire world emerges from the pandemic, it was reported that the ORA is holding “listening sessions” to see […]
As of November 16, 2022, the OGD has published the issuance of thirty‑three full‑approval actions and four tentative‑approval actions. With Thanksgiving around the corner and the predictable number of staff off on PTO, the back‑end of November might not be as productive as the first half. We will keep an eye out and post an […]
In its never-ending quest to provide timely guidance on bioequivalence requirements for generic versions of brand name products, today, the FDA published 29 new and 20 revised BE guidance recommendations in the pre-publication of Federal Register Notice (here) as well as on their website (here, hint: look for the newly added and revised links on […]
Outsourcing your facilities management program is a great way to reduce the burden on internal resources—but it can also expose your business to greater risk and non-compliance. We’ve got you covered. Earlier this month, Lachman Consultants’ Data Integrity Consultant Patrick Day hosted an insightful and interactive webinar, Outsourced Facilities Management, aimed at helping businesses manage […]
The opioid/fentanyl crisis, along with the abuse of other opioid‑based products, has put the prospect of an over‑the‑counter (OTC) version of naloxone high on the FDA’s priority list. Making the product available in a ready and easy‑to‑use format (for instance, a nasal spray or autoinjector) would increase the availability of this potentially life‑saving drug. Now, […]
At the AAM GRx+Biosims meeting last week in North Bethesda, Maryland, Ted Sherwood, Director of the Office of Regulatory Operations, Office of Generic Drugs, indicated that the negotiations for GDUFA III had led to a number of program enhancements in the generic drug review and approval processes. He outlined a number of these changes from GDUFA II […]
One of the closing sessions at the recent Association for Accessible Medicine’s GRx + Biosimilars conference covered Post-Approval Changes to Complex Generic Drugs. The session included presentations from multiple individuals from FDA, as well as from industry, to provide a breadth of perspective on this subject. As one would expect, the session did offer both […]
Day two of the Association of Accessible Medicine (AAM) Generics and Biosimilars Conference, which took place on November 8, 2022, started with plenary session presentations from Dr. Susan Rosencrance, Acting Director, Office of Generic Drugs (OGD), Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality (OPQ), and Donald Ashley, JD, Director, Office of Compliance (OC) with the FDA. […]
Two years after the FDA guidance on Control of Nitrosamines Impurities in Human Drugs and nearly a year after the publication of USP’s General Chapter <1469> Nitrosamine Impurities, where are we now and what have we learned? That was a question posed recently at the Association of Accessible Medicine’s GRx+Biosims 2022 conference. The session devoted […]
