The Incoterms rules are frequently used in international and domestic contracts. In this article, you will get an overview of the Incoterms 2020 and their meaning.
The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors (the "Green Guide"), compiled by the Medicines and Healthcare products Regulatory Agency (MHRA), was published. It provides an authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities.
On either 02 or 03 February 2022, interested parties could take part in a live webinar of the Medicines and Healthcare products Regulatory Agency (MHRA) on Medicines Supply to Northern Ireland. A recording of the webinar, excluding the Q&A sessions, was now published.
In December, the FDA updated its important information for blood establishments and transfusion services on bacterial contamination of platelets for transfusion, which has been published since 2016.
The FDA issued again Warning Letters to several companies for selling Cannabidiol (CBD) products with misleading product claims.
In March 2022, the U.S. Food and Drug Administration (FDA) sent a Form 483 to Cadila Healthcares sterile injectable manufacturing site in Jarod, India. Among other observations, it came out that the stability program is not followed to complete the testing within the predefined time frame. Some tests were even delayed by more than 120 days.
The English translation of the Japanese Pharmacopoeia (JP) 18th edition is available for download free of charge.
The FDA has issued a questions and answers document to assist industry and State and local governments in understanding the effects of the Uniform National Policy on drug product tracing.
The US Food and Drug Administration (FDA) is trying to revive its somewhat forgotten Quality Metrics Reporting Program. Now the FDA is asking for specific feedback.
On March 24, the drafting process of the new ICH Guideline Q14 Analytical Procedure Development and the revised Guideline Q2(R2) Validation of Analytical Procedures reached Step 2, and both were published for consultation by ICH members.