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The draft guidance document provides recommendations for complying with 21 CFR 211.110.

FDA Releases Draft Guidance on Sampling and Testing of In-Process Materials and Drug Products

Feliza Mirasol is the science editor for 

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.

FDA Announces Reopening of Comment Period Regarding HCP Immunogenicity Risk from Follow-on Recombinant Peptides

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

FDA Publishes Final Guidance on Advanced Manufacturing Technologies

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow. Here are the CDMOs and service providers that are poised to make the biggest impact on the pharmaceutical industry. 

5 CDMOs to Watch in 2025

The company is recalling one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because some bottles may contain empty capsules.

Astellas Pharma Recalls PROGRAF and ASTAGRAF XL Capsules

The PharmTech Group editors present our most popular technical articles from 2024.

First Generic of a GLP-1 Injection Gets FDA Nod to Treat Type 2 Diabetes

Pointing to the continued circulation and evolution of COVID-19, WHO published a statement on the COVID-19 vaccine antigen composition to respond to variants of the virus.

WHO Provides a Statement on COVID-19 Vaccines

Revised guidelines published by EMA and HMA update the rules on identification of commercially confidential information and personal data used in marketing authorization applications.

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