On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing. On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required). Congress has been pushing […]
Over the years Lachman Consultant Services, Inc. has participated in and donated to volunteer-based and charitable organizations as part of our corporate social responsibility (CSR) program. Our overarching value is in our ability to assist our clients as they help their patients, but equally as important is using our skillsets and our reach to help […]
The industry as a whole rejoiced on Friday with the publication of the new NDSRI guidance from the FDA, previously discussed here. Now that we all have had more time to carefully read and absorb the details posted by the FDA in the guidance and on the corresponding webpage, many will discover that there are […]
It has been more than a year-and-a-half since the FDA released its publication “An update to the Resiliency Roadmap for FDA Inspections.” Are you among the many companies wanting to stay current and who can benefit from some assistance in creating an executable year-to-year plan to maintain both long and short-term inspection proactivity? If so, […]
Join Lachman Consultant Services, Inc. at PARKROYAL on Beach Road, Singapore for the 2023 PDA Pharmaceutical Manufacturing and Quality Conference, August 15th – 16th. The conference theme is “The Way Forward: Trends, Technologies and New Regulations Transforming Pharmaceutical Manufacturing.” Lachman Consultants is pleased to have Scott Deckebach, Senior Director of Data Integrity and Compliance, as […]
According to currently published figures as of July 6, 2023, OGD has issued 68 full approval actions and 15 tentative approval actions for a total 83 total approval actions for the month. The 68 full approval actions represent the third highest number per month for the 10 months of FY 2023 and the 83 total […]
Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products. As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]
Join Lachman Consultant Services, Inc. online and in-person at Suntec Singapore for the 2023 ISPE Singapore Affiliate Conference & Exhibition, August 23rd – 25th. The exhibition showcases the latest technologies and services for pharmaceutical and biomanufacturing. The three-day conference is expected to include more than ninety international exhibitors and sponsors. Lachman Consultants is pleased to […]
What do a cup of cappuccino and sterile water for injection have in common? At first glance, there is no apparent correlation, except when you become “data curious” and take the macro view of the current convergence of economics, compliance, and maturation of risk management. Sometimes utilizing existing data is the best way to understand […]
The statistical report (here) provides full official statistics through the third quarter Fiscal Year (FY) 2023. There is some good news when looking at mean and median approval time that we will discuss later. But for now, let’s look at some of the more important FDA approval actions for June 2023. OGD approved 76 new […]
