How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...
Top 9 Failure Points During Nonclinical Development
The process of drug development involves clinical and nonclinical studies. Nonclinical studies are considered crucial for understanding the safety of new drugs. Before testing a drug in people,...
Stability Testing of New Drug Substances and Products
The stability of a drug substance or product is a critical attribute for all pharmaceutical products. As such, stability testing is required throughout the drug development phase as well as...
The Truth Can Hurt - But Hearing It at the Right Time Can Save Time and Money
No one has an ugly baby. At least, no one thinks their baby is ugly. Every new parent thinks their baby is the most beautiful baby of all time. But the unfortunate fact is that there are ugly babies....
2020 in Review: Reflecting on the Biggest Events & Breakthroughs
2020 has been an unusual year. You could also describe this year as different, difficult, and challenging, just to list a few – the list could go on for days. And yet, this year leaves us with...
4 Common Bottlenecks to Avoid in the Development of Biopharmaceuticals
If you are involved in early development of biopharmaceuticals, have you ever experienced serious delays because of problems arising from tech transfer, from the first pilot scale batches not meeting...
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...
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...
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....
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...
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...