Once again, with October approval action postings surprisingly low, I confirmed that the FDA is still having trouble with its internal IT systems that generate this information and populate certain databases. While it does not appear to be impacting data regarding NDAs, the ANDA postings are spotty at best. The word came back from OGD […]
Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]
Yesterday, the FDA issued a draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (here). If you can get that out of your mouth without taking a breath, I think you must be a free diver. The issue of disseminating information […]
On September 30, 2023, the Animal Drug and Animal Generic Drug User Fee Amendments of 2023 were signed into law as part of H.R. 5860. The amendments reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) programs administered by the U.S. Food and Drug Administration until 2028. But not […]
Jim Jones was appointed Deputy Commissioner for Human Foods in August 2023. Through the leadership of FDA Commissioner Robert M. Califf, M.D., the overhaul of the FDA’s food program is getting well-deserved additional attention as it protects our food supply and dietary supplements. Under the new unified Human Foods Program (HFP) to be led by Jones, […]
If you are responsible for data integrity for your company and you limit your thinking to Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), you may be creating your own vulnerability. For too long, the “unloved” business continuity plan has been a paper exercise rather than a true investment in protection of a true […]
Lachman Consultant Services, Inc. is proud to announce that the prestigious Joseph X. Phillips Professional Achievement Award has been given to Lachman’s President & CEO, Frances M. Zipp. The award was announced during an awards ceremony held on October 16, 2023, at the International Society of Pharmaceutical Engineering (ISPE) Annual conference. Fran graciously accepted the […]
On the heels of additional reports of methanol poisoning from ingestion of hand sanitizers, the FDA issued a new final guidance titled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol (here) for immediate implementation. The guidance applies to the use of pharmaceutical alcohols (PAs) (ethanol and isopropyl alcohol) by pharmaceutical manufacturers, outsourcing […]
Remember the good old days, when a dosing spoon or cup was dispensed with liquid medication and a product in a prefilled syringe was just a drug? Well, we know now that those days are over, and maybe they should be. The presentation by three FDAers, Markham Luke, MD, PhD, Karyn L. Berry, MD, MPH, and […]
ISPE 2023 Annual Meeting Mandalay Bay Resort Las Vegas, NV October 16th – 18th, 2023 We are looking forward to seeing you at the 2023 ISPE Annual Meeting & Expo. This annual event will usher in a revitalized focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. MEET WITH LACHMAN CONSULTANTS AT BOOTH […]
