Regulatory Sciences
5 Tips for Achieving Regulatory Success in 2021
As we begin to wrap up the year and look ahead to 2021, it is critical to prepare your team for what is coming in the weeks and months that lay ahead. Preparation and preparedness are key to ensuring...
A Roadmap to Authorization: Using Science to Prepare a MAA
As you move from Phase 3 clinical trials towards your Marketing Authorization Application (MAA), there are a number of critical steps that must be taken regarding how you interpret your clinical...
Meet the Expert: Matthew Weinberg
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
Regulatory Sciences
Why Drug Approvals Are Never Slam Dunks
It's the FDA, Not the NBA Aside from being a spectacular thing to watch, the slam dunk is the highest percentage shot a basketball player can take. The likelihood of getting the ball in the basket is...
Regulatory Sciences
Filing Using Registry-Based Studies? EMA Issues Draft Guidance
Recruiting clinical studies in a niche disease area can be challenging, but disease registries can provide the solution. The European Medicines Agency (EMA) has issued draft guidance on how...
10 Things You Need to Know about FDA’s Final Rule on Importing Prescription Drugs from Canada
Last week, FDA issued a final rule regarding the importation of certain prescription drugs from Canada. This action was taken by the agency as part of the Safe Important Action Plan, and was done in...
Regulatory Sciences
Biosimilars: How the Approval Process Differs from a Standard ANDA
Biosimilars, by their very nature, are different from generic drugs. The core difference is that generic drugs are chemically synthesized, while biosimilars are grown in complex living systems....
Regulatory Sciences
Why It's Smarter to Play the Long Game When Planning Your FDA Submission
The drug development process is long and expensive. You are doing yourself and your product a huge advantage if you enter and go through the process with a well-researched plan. When planning your...
Quality & Compliance
How to Ensure Your Device, Software, and Drug Are All Ready for a Pre-Approval Inspection
When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a...
505(b)(1) vs. 505(b)(2): Choosing the Appropriate Regulatory Pathway
Because the FDA is an agency established by a federal law, there are clearly defined pathways along which a drug can be approved. Deciding on the appropriate regulatory pathway for your drug...
What You Need to Know About the ICH
The FDA has a strong interest in promoting the health and safety of U.S. citizens; in addition, it also supports the advancement of the global harmonization of regulatory requirements and practices....
Regulatory Sciences
FDA Announces Plans to Resume Domestic Inspections with New Risk Assessment System
On Friday, July 11th, Stephen Hahn, MD, Commissioner of the FDA, issued a Coronavirus (COVID-19) Update, announcing the Agency's plans to resume "prioritized domestic inspections of FDA-regulated...
Improving Cost Efficiency, Speed, and Completeness of Generic Applications
An abbreviated new drug application (ANDA) is a “streamlined” marketing application that is submitted to the FDA for review containing information and data about a generic drug product. Once...
Regulatory Sciences
How Should You Respond & React When Employees Become Infected with COVID-19?
On Friday, June 19th, the FDA issued a guidance document explaining what manufacturers of drugs and biological products should do, if and when, employees become infected with COVID-19. The...
Regulatory Sciences
How Opioid Analgesic Drugs are Approved by the FDA
The benefit-risk assessment is the cornerstone of how all drugs are approved. This assessment captures the scientific evidence, uncertainties, policy, and reasoning used by FDA officials to arrive at...
3 Factors to Consider in the Manufacturing Phase for Drug Device Combination Products
Combination products represent an important and growing category of therapeutic and diagnostic products. They come in several configurations and can be composed of any combination of a drug and a...