How a monograph, general notices, and general chapters relate to good manufacturing practices.

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Careful analysis of CMC factors ensures no problem areas are overlooked.

Due Diligence Assessment of CMC Activities

Topic

Articles

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19. 

FDA Grants Fast Track Designation to ARCA biopharma’s Potential COVID-19 Treatment

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy. 

EC Approves Bristol Myers Squibb’s Opdivo in Second-Line Treatment of Esophageal Cancer

The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.

EMA Recommends Breast Cancer Treatment and Four Other Medicines for Approval

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

EMA Publishes Risk Management Guidance for COVID-19 Vaccines

The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.

EMA Issues Safety Monitoring Plan for COVID-19 Vaccines

The guidelines are part of the independent control of pandemic COVID-19 vaccine batches. 

EDQM Publishes Guidelines on Batch Release for COVID-19 Vaccines

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The first public announcement from the Biden-Harris transition team was to name members of a COVID-19 advisory board charged with initiating policies and actions to combat the fast-rising infection rate in the United States.

Tackling COVID Top Priority for New Administration 

Kevin E. Noonan, PhD, is a partner at McDonnell Boehnen Hulbert & Berghoff LLP.

Opposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.

Protecting Intellectual Property for COVID-19 Innovations

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress. 

Technology’s Role in QA/QC

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

Quality/GMPs

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Due Diligence Assessment of CMC Activities