FDA warning letters have doubled since 2015 and more than 50% of observations involve data integrity. Fines up to $1 million per incident are possible. Get prepared and avoid the fines. “The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no liability for the accuracy and completeness […]
The must pass User Fee Reauthorization Bill has a lot of amendments tacked on and provisions are starting to come into focus. But remember- the final Bill mark-up by the House and the Senate will be the only time we will know for sure what’s in and what’s out. As of today, it appears that […]
There has been legislation introduced recently to change the provisions as to how the 180‑day award for being a first filer in a paragraph IV patent challenge works. The FDA has proposed some alternate changes as well, outlined in a current blog by our friend Kurt Karst (here). If you want your head to spin […]
Now, HERE is a Q&A document that makes the how, who, why, and when very clear. This Q&A final guidance outlines responses to a question that the Agency has fielded since the final rule regarding importation of prescription drugs went into effect on November 30, 2020. Of importance, this rule does not cover individual personal […]
In today’s blog, we want to create awareness that, after sixteen years, in May of 2022, the FDA has finally announced revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. (here). Specifically, this revision updates terminology for consistency with current FDA guidance, e.g., the quality control unit “QCU” is changed to the […]
Yesterday, the Office of Generic Drugs released twenty-four new and thirteen revised Product Specific Guidances (PSGs) with recommendations for conducting studies necessary to establish bioequivalence between test and reference products. Of course, the revisions might spell trouble for applicants that have already commenced testing according to the original guidances, but this has been a bone […]
At the MedTech Forum 2022 in Barcelona, there was a tense and “standing room only” moderated session on the looming May 26, 2024 EU Medical Device Regulations (MDR) implementation deadline. Representatives from the notified bodies, competent authorities, industry, and other trade groups had a very intense interchange about the deadline, which requires all companies selling […]
You may need some time to read this recently published guidance entitled, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (here), as it is 41 pages long. There is lots of good information contained in the document and, while it may contain most of what you know about labeling requirements, […]
Surprise, surprise! Just yesterday, we reported an anemic number of approvals through May 16th and today we were surprised to see (perhaps due to a fix to the FDA’s posting problem!) the new and now revised total through May 17th is thirty‑seven full‑approval actions (only one of which was approved on the 17th) and still one tentative […]
According to the reporting on the FDA’s Daily Approvals page and confirmed by the FDA’s All Approvals list at 9:45 AM, EST 5/18/22, there were a total of 15 full approval actions and one (1) tentative approval action so far in May. Could the glitch previously reported here still be a problem? We all hope […]
