Quality/GMPs

Articles

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

Application for COVID-19 Treatment Submitted to EMA 

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

EMA Recommends Boosters of Pfizer and Moderna COVID-19 Vaccines for Some Individuals

Jaap Venema, PhD, is Executive Vice President and Chief Science at US Pharmacopeia (USP).

Jennifer Devine, JD, is Senior Vice President, Documentary Standards and Compendial Policy at US Pharmacopeia (USP).

Public health challenges have highlighted the need for agility in maintaining the quality of medicines. 

Public Trust in Medicine Quality as Public Health Challenges Emerge

 Washington Editor, jillwechsler7@gmail.com.

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

FDA Moves to Advance Innovative Excipients

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of BioPharm International's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

The Basics of Aseptic Processing

The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.

FDA Caught in the Political Crossfire

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

FDA and EMA Launch Program to Advise Prospective MAAs and ANDAs Applicants

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

Contaminant in Moderna Vaccines in Japan Suspected to be Metallic Particles

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements. 

FDA Offers Guidance on How to Include Bioequivalence Info in ANDAs

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

Regulatory/GMP Compliance