Visit with Lachman Consultants at Booth #314 during the event. We hope you’ll be joining us at the annual PAD/FDA Joint Regulatory Conference on September 9th-11th at The Westin Washington, DC Downtown. This years can not miss event is entitled Current Good Manufacturing Practice (CGMP): Leading with Quality and Integrity,” and will provide in-depth knowledge […]
Join us at this year’s conference for a great exchange of ideas, and the celebration of FDLI’s 75th Anniversary! Lachman Consultants is excited to be part of the upcoming 2024 Food and Drug Law Institute (FDLI) Annual Conference, scheduled for May 15-16 in Washington, DC. The conference serves as an invaluable platform for professionals across […]
Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA. Are you among the many […]
In case you didn’t have the opportunity to attend the GRx+Biosims 2023 conference or were there and want to revisit the featured panel on nitrosamine impurities, here’s a quick recap and a link to the full Contract Pharma article, authored by Jennifer Leaming, Principal Consultant, Lachman Consultants. Four presentations were made by FDA representatives on […]
The “race to the bottom” for cost and the cumulative effect of “lean-out” global supply chains have had an unintended consequence for the safe, reliable supply of product. Third-party management has become a growing and recognized risk. And then there’s fourth- and fifth-party management. They are all-important parts of supply chain challenges in today’s increasingly […]
Have you ever had a tough time understanding some of the more complex guidance documents that the FDA issues that fall outside our specific areas of expertise? Yes, if we are being completely honest, it has probably happened to us all at one time or another. Fortunately, it’s about to get easier thanks to an […]
Those of us in the industry are usually reasonably technically savvy and can understand some of the more complex guidance documents that the FDA issues. However, there are times that even those among us in the industry, depending on our individual academic tracks and professional experiences, whether regulatory, CMC, bioanalytical, pharmacokinetics, medical, and on and […]
CDER has issued the final guidance, ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products, which provides for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM), applying to both drug substances and drug products for chemical entities, therapeutic proteins for new products, and conversion of existing products. A copy of the guidance […]
There is no question that GDUFA III has brought with it a lot of changes. OGD has begun issuing Guidances and MaPPs to reflect the changes and updating those document that were issued under previous iteration of GDUFA. Rather than trying to paraphrase each Guidance and explain what changes have been made in the past […]
In a Federal Register notice titled Effects of the COVID‑19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised); Withdrawal of Guidance (Docket No. FDA-2020-D-1138), which appeared in the prepublication section (usually meaning it will become official the next day but, because of the weekend, the final publication […]
