Regulatory Oversight and Compliance

FDA Faces Huge Task Catching Up on Inspections

February 08, 2022

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

FDA Approves Bispecific Antibody to Treat Vision Loss

February 07, 2022

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

Politics Impact FDA

February 07, 2022

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

Janssen Seeks European Approval of Teclistamab

February 04, 2022

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

NICE Recommends Forxiga for Marketing Authorization

February 04, 2022

The UK’s NICE issued a Final Appraisal Document recommending marketing authorization for AstraZeneca’s chronic kidney disease treatment, Forxiga (dapagliflozin).

What’s in Your Quality Manual?

February 02, 2022

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.

The Data Relationship

February 02, 2022

As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.

Global Vaccine Access Challenges FDA and Industry

February 02, 2022

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

Updated Guidance to the EU’s Digital Markets Act

February 02, 2022

The Digital Markets Act is transforming the use of digital content by the pharmaceutical industry.

Predicting Toxicity in Drug Development

February 02, 2022

Toxicology studies are an important and required aspect of drug development that are performed to ensure that drugs are deemed safe prior to patient administration and use in clinical trials.