How market exclusivities can affect your development program

Five points to remember if FDA issues a Form 483

GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...

FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices.  Numerous...

Navigating new steps in how FDA is managing COVID-19 Products

Biosimilars in the time of COVID-19 and beyond

Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...

Considerations for protecting your business and employees from COVID-19

This assessment highlights some planning considerations to help you maintain business operations, while protecting the safety of employees and customers during this pandemic.

Understanding the COVID-19 regulatory procedures the FDA is using

A diagram that shows various procedural steps when interacting with the FDA through CTAP.

Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?

Understanding Department of Justice Enforcement Policies relating to FDA-Regulated Products

At the recent 2019 Enforcement, Litigation and Compliance Conference hosted by the Food and Drug Law Institute (see here), Deputy Assistant Attorney General David Morrell delivered the...

What Influences the Compliance Culture at FDA?

The Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) is a large organization.  It has hundreds of personnel who are...

FDA & Nitrosamine Impurities – The Proverb of the King with Long Arms

If the dictionary is to be believed, the expression that kings have long arms was first listed as a proverb in 1539 (see here).  Over time it has developed into the commonly recognized idea...

As PIC/S expansion continues, what does this mean for manufacturers seeking to join?

Over the last few years the expansion of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has continued at pace, with more Good Manufacturing Practice (GMP) Inspectorates joining,...