Regulatory Oversight and Compliance

August 08, 2023

Lower levels of an active ingredient may result in unexpected pregnancies.

August 03, 2023

The nasal-spray drug can be used to reverse the effects of opioid overdose.

August 02, 2023

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

August 02, 2023

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

August 02, 2023

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

August 02, 2023

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

August 01, 2023

The program aims to aid submissions from external stakeholders and FDA staff.

August 01, 2023

The guidance document outlines recommendations to limit potential carcinogenic risk.

August 01, 2023

In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.

July 28, 2023

Pandemic, PBM, and other policies on hold during the summer recess.