The FDA published the final guidance on standards for the interoperable exchange of track & trace information for certain human prescription drugs.
In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.
The World Health Organization (WHO) published a draft guideline on best practices for clinical trials. The document is intended to provide guidance to WHOs Member States and any staff members of non-State actor organizations whose work is related to clinical trials.
On 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle. This document is open for comments until 31. December 2023. What is the content of the document?
The U.S. FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct).
The latest valid version of the USP chapter "Balances <41>" has been substantially revised and is now posted for comment on the USP Pharmacopeial Forum website. This revision follows updates to the USP chapter "Weighing on an Analytical Balance <1251>" and the general chapter "Balances" of the European Pharmacopoeia (Ph. Eur.). Comments on this draft can be submitted until 30 November 2023.
Swissmedic plans to bring a SwissGMDP database into operation, which will list the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. The database will make it possible to view the GMP/GDP status of a company easily and free of charge.
To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.
Swissmedic is bringing a SwissGMDP database into operation, similar to the EudraGMDP database, listing GMP and GDP certificates of all companies in Switzerland.
In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.