A presentation delivered by Office of Generic Drugs Director, Iilun Murphy, M.D. during the members-only Regulatory and Policy meeting at the start of AAM’s annual meeting provided seven tips for ANDA sponsors with regard to their ANDA submissions: Submit a clear cover letter. Describe what is being submitted. State whether the submission includes a labeling […]
The 101-page Federal Register (FR) document published on the prepublication page of the FR today (here) describes the rule in detail and provides responses to comments received by stakeholders on the proposed final rule. The FDA states: “We are amending part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes. […]
Some of the big-ticket items mentioned in the FY 2023 report are Office of Compliance (OC) actions taken regarding the “contamination from diethylene glycol and ethylene glycol (DEG/EG), potentially harmful eye products, and mitigating risks from drug shortages while ensuring the safety our drug supply.” These issues caused the OC to “pivot” from its business as […]
Have you ever found an Empower 3 chromatogram with no plot and the message “Incomplete Data”? You might have assumed that there was a system glitch, resulting in no data being acquired for the injection. However, data may have been acquired and can only be viewed if you have the appropriate permission(s). A search of the […]
In 2011, the FDA published the draft “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency” (here) that established the way that the FDA would prioritize, develop, and release guidances in draft or final, and identified two levels of guidances, a so-called Level 1 and Level 2. A Level 1 guidance document is one […]
With 2024 coming up fast, we thought it would be good to look back at some of the more impactful changes to the quality landscape that came about this past year. Here are just some of the stories from the Lachman blog that exemplify a productive year 2023 for our industry. Get Ready for […]
Have you reviewed your audit trail lately? What is it telling you and your team? We all understand the importance of audit trails, and companies review audit trails in one way or another, but does your staff truly understand what the audit trail is stating? Processes in a GxP environment should be developed and implemented […]
Last week, the FDA has announced the availability of two draft Guidances for Industry regarding compounding of human drugs: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (here); and Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and […]
Yesterday, the FDA issued the first revision of the Guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (here). This Guidance covers the following four topics: Providing quantitative efficacy or risk information for the control group, when applicable; Presenting probability information in terms of absolute frequencies, percentages, and relative […]
This blog post focuses on the unprocessed, processed, and re-processed chromatographic data (e.g., data generated using chromatographic instruments such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Performance Liquid Chromatography (UPLC), etc.). To some operators, the unprocessed chromatographic data might not be recognized, nor would they raise any concerns with the validity of the […]
