Over the last eight months, a number of priority vouchers were sold by firms that were subject to the award of either a tropical disease priority review voucher, a rare pediatric disease priority review voucher, or a material threat medical countermeasure (MCM) priority review voucher. The purchase prices of these vouchers, while not as high […]
As a refresher, a reference listed drug (RLD) product for which sale has been discontinued or for which the firm has withdrawn its approval for commercial reasons and that was relied upon as the basis for submission of an ANDA creates a regulatory problem for firms that have approved ANDA versions or drug products with […]
Lachman has blogged many times on the topic of nitrosamines over the last several years as the FDA has issued and revised guidances providing its recommendations for assessment and control of nitrosamine impurities. The published deadline for compliance with these recommendations is quickly approaching; it’s just over three months until the August 1, 2025 compliance date […]
Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust. Imagine […]
Given all that’s happened with the federal government this past week, it’s no wonder that we’re not hearing much from the OGD. Communications appear to be quite slow to appear. Even the Federal Register prepublication page has few FDA postings over the last three weeks. Another instance of communication lapse: since March 7, 2025, only safety […]
April Fool’s Day was a difficult day for many FDA employees, because that was when many of them found out they were let go as they attempted to enter FDA’s White Oak HQ by swiping their badges at the entry gates. With many significant Offices and Division cuts, there are questions of how those cuts […]
On March 28, the FDA issued a notice (here) informing pharmaceutical companies that have submitted in vitro and in vivo bioequivalence studies in applications that were conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based in Navi Mumbai, India, that it has “identified significant data integrity and study conduct concerns” in certain studies in […]
In a pre-publication notice in the Federal Register today (here), the decision on the issuance of the rule will be kicked down the road another sixty days until May 21, 2025 so the FDA/administration can fully vet the rule. This is the second delay since it was published as “a final rule, titled ‘Nonprescription Drug Product […]
After a March 6, 2025 report from an independent testing facility claimed that a significant number of acne products containing benzoyl peroxide were found to have very high levels of benzene (here), the threat has been countered by the FDA’s own testing of 95 products. After the FDA’s testing results were confirmed, it announced that the “FDA […]
As consultants we have the privilege of assisting many clients with FDA communications on a variety of topics and working with them to support many different types of drug product applications. Through our work we often identify common themes or issues that our clients are facing and one of the biggest headaches for our ANDA […]
