On Thursday, June 30th, at the Annual Conference of Medicines for Europe, Frances Zipp, President and CEO of Lachman Consultant Services, Inc., will be addressing the audience as a part of the Keynote Speech at the Dolce Sitges Hotel in Barcelona, Spain. Fran will be addressing humanitarian efforts by industry to provide patients in war-torn […]
The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion. People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation. Thus, quality metrics were held tightly close to the chest of business leaders. Deming identified this […]
The FDA issued a warning to consumers (here) that mole removal isn’t a DIY project and can be dangerous for a number of reasons. It warns that there is no FDA-approved OTC product for removing moles or skin tags. Unauthorized products, like those with a high‑level of salicylic acid, claiming to remove these lesions can […]
The FDA has updated its list of all ANDA final approvals for drug products that have received CGT designation. The list cites a total of 150 ANDAs and the first approval under the program dates back to August 8, 2018. So far in 2022, FDA has approved 29 such ANDAs, of which 10 have commenced […]
The FDA’s Pharmacy Compounding Advisory Committee will be considering the addition of four new ingredients for use for inclusion on the bulk list for 503A compounders to utilize in the compounding of prescription drug products. The four ingredients up for consideration are: Ammonium tetrathiomolybdate; Enclomiphene citrate; Ferric subsulfate; and Glutathione The Notice for the Advisory […]
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 […]
Keith Lamb reveals why readiness to begin GMP manufacturing is a decision point that requires careful consideration and what those important considerations should include and why. The article explains why the first patient treated with any new drug is a significant milestone, and achievement for every project team. It is also a measure of progress […]
The “rain” of approval actions in April led to an unofficial “sprouting” of 83 full approvals in May, which was the largest number of full approvals seen in quite some time; specifically, since May 2019 when there were also 83 full approvals. While not an all-time high for a single month, it is a welcome […]
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 […]
