FDA finalizes residual solvent guidance
This article was originally published in The Tan Sheet
Executive Summary
Manufacturers of compendial drug products approved under a new drug application or in an abbreviated NDA may submit an analysis from a properly qualified component supplier to prove the required level of control of residual solvents in the finished product, an FDA final guidance says. The 1guidance notes FDA requires U.S.-marketed drug products with a U.S. Pharmacopoeia monograph to meet the requirements for control of residual solvents described in USP General Chapter 467. The guidance might still create a hurdle for approval of some generics, many of which were held up by FDA's initial interpretation of the revised USP standards last year. Under the final guidance, non-compendial products must follow an International Conference on Harmonization guideline - Q3C Impurities: Residual Solvents. Differences between the ICH requirement and USP's could be an issue for firms seeking to launch an ANDA product quickly
You may also be interested in...
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”