When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]
The focus on beta‑lactam antibiotics has primarily concentrated on penicillin and its derivatives because of the issue of severe allergy or anaphylaxis that can occur in individuals with sensitivities to these products. Over the years, as more and more non‑beta‑lactam antibiotics were introduced to the market, there has also been growing concern that these new […]
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’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 […]
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 […]
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 […]
When reviewing health agency citations, investigators are naturally concerned when observing cases of data invalidation during investigations and may well question the motives/justification accordingly. This can lead to some uncomfortable exchanges between firms and health agencies! So how should a laboratory protect themselves from such a situation? First, you want to ensure that, per your […]
The FY 2022 Generic Drug Science and Research Initiatives Public Workshop held May 9-10, 2022, addressed a significant number of complex drug product questions as well as feedback from the industry as to what steps would be helpful for FDA to undertake to facilitate complex product development, review, and approval. With GDUFA III considered to […]
In a previous blog post (here), we discussed the results of an April 16, 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 (U.S. App. Lexis 10928 [April 16, 2021]) which the FDA decided not to appeal. This court decision dealt with […]
