The OGD is off to a good start in 2025, with 31 full-approval actions and 14 tentative-approval actions for a total of 45 approval actions posted as of January 16. While this number is not as high as the number of Executive Orders signed by Trump in his first day back in office, if the […]
I remember when I was at the FDA and presenting at a meeting discussing a guidance that industry had been waiting for the FDA to publish for a year or so. I noted that it would be released soon! Immediately someone from the audience asked, “what’s the FDA’s definition of soon?” I thought for a […]
Lachman Consultants has continued its active engagement with efforts to combat the global drug supply chain shortages. Despite the FDA’s significant success in helping to prevent 236 drug shortages in 2023, the problem persists and may be about to get worse. The current problem, external environment, and emerging risks are highlighted in a recent publication […]
Some common FDA 483 citations pertaining to cleaning validation are regarding consistency in monitoring of cleaning and the complete documentation of cleaning. It is critical to implement a robust monitoring process that is supported by detailed documentation. Ensuring that the SOPs for all aspects of cleaning are clear, detailed, and contain illustrations (where appropriate) to ensure […]
For those of you that have been following the saga of the attack on the skinny label, we may be getting close to a solution. Remember that a skinny label is labeling that cuts out a particular use or information protected by patent or market exclusivity of the branded product. This allows for a generic […]
In the latest CDER Science Spotlights, available (here), the FDA provides some insight into the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine recommended acceptable intake limits of N-nitrosamine impurities in drug products. The latest revision of the Nitrosamine Impurity guidance updated in September 2024 (here) provided better integration of the overall assessment […]
The OGD published the second month of the Fiscal Year (FY) 2025 statistical report titled, Generic Drugs Program Monthly and Quarterly Activities Report (here). There is some continued good news and also some troubling news in the report. On the positive side, we previously reported (here) in our unofficial posting, the full approval actions as […]
If you received one or more reminder emails in November 2024 asking your firm to submit 2023 CARES Act reports, you are not alone. In 2024, the FDA emphasized the importance of CARES Act reporting and the Agency’s need for the data contained in those reports at several conferences, but there have continued to be […]
The pharmaceutical industry is entering a transformative era with the Food and Drug Administration’s (FDA) newly established pathway for nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU), with the final rule announced in a December 2024 Federal Register Notice (here). This new rule aims to broaden consumer access to safe and effective […]
The OGD had some late-month stocking stuffers as it issued 68 full-approval actions and 16 tentative-approval actions for a total of 84 approval actions in December. Despite the hectic holiday schedule, if these numbers are confirmed in the official totals for the month, it would mean that the OGD managed to tie the second highest […]
