EMA has today published a draft question and answer document on the remote certification of batches by the Qualified Person (QP).
After the revision in 2017, the Monograph 2.6.30. Monocyte Activation Test in the European Pharmacopoeia undergoes a new revision which is open for comments until the end of June.
The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.
During its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of general chapter 5.21. Chemometric methods applied to analytical data to be published in Ph. Eur. Supplement 11.1 and be effective as of 01 April 2023.
Following the recently adopted USP general chapter <665> for plastic materials used in manufacturing, the USP now published two draft chapters for elastomers for pharmaceutical packaging and manufacturing.
To assist sponsors and authorities in fulfilling the transparency requirements set out in the Clinical Trials Regulation, the EMA is preparing a dedicated guidance on the protection of personal data in the CTIS. The agency has published a public consultation document to allow for wider stakeholder input.
The ICH E11A draft reached Step 2 of the ICH process. The guideline describes the extrapolation framework consisting of the pediatric extrapolation concept and the pediatric extrapolation plan.
The EMA published guidance for applicants / MAHs involved in GCP inspections. It includes a detailed list of documents to be provided to GCP inspectors.
Currently, several GDP-relevant documents from the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) are in the commenting process. We have prepared an overview.
The U.S. Food and Drug Administration (FDA) has posted a webinar on the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The webinar aims to help stakeholders submit comments and understand the proposed changes.