Rethinking Biometrics Resourcing in Modern Clinical Trials
Rethinking biometrics as a strategic function to improve consistency, scalability, and clinical trial performance.
Quality & Compliance
FDA's Top 483 Observations for 2018: A Reflection of Industry’s Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year's Form 483 observation metrics issued by each product center. Inspections ending between 10/1/2017 and 9/30/2018, for...
Utilizing an Agile Framework When Implementing ATMPs
Who says you can’t teach an old dog a new trick? Having spent the last 25+ years in small molecule, large molecule, medical devices, I have spent a lot of time planning and executing everything from...
Meet the Expert: Mary Speckin
ProPharma Group has launched a "Meet the Expert" series to introduce 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 support...
Regulatory Sciences
How to Survive a Multi-Year Consent Decree
Operating a business under a Consent Decree is extremely difficult; there is no area of the business that goes unaffected. In addition to fines that could reach $500 million, a three to five-year...
FDA Announces Update to Nonproprietary Naming Convention for Biosimilar Products
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...
Quality & Compliance
Assumed Brexit & Batch Control Testing Site In the UK
The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the...
Regulatory Sciences
FDA Approves Nasal Spray to Treat Depression in Adults
Earlier this month, FDA announced the approval of Spravato (esketamine) nasal spray. The product is to be used in conjunction with an oral antidepressant and is indicated for the treatment of...
Health Apps and the Requirements Imposed By the Law
If you check Apple’s App Store or Google’s Play Store you will find an overwhelming list of health and fitness apps. This list only gets longer, if you include the number of people who use these...
7 Things to Consider in Medicinal Cannabis Development
Mention the word cannabis and the confusion starts; legal or illegal, nutraceutical or medicinal product, psychoactive or non-psychoactive, clinically significant or not. At the same time, the...
Regulatory Sciences
FDA Issues Draft Guidance to Advance Development of Combination Products
On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...
Clinical Research Solutions
FDA Draft Guidance on Tentatively Approved ANDA Submissions
On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22, 2018. The draft guidance, entitled "ANDA Submissions –...
Regulatory Sciences
Year in Review: Taking a Look at Pharma's Top News Stories & Events from 2018
From FDA's approval of the first cannabis-based product in the U.S., to the classification of two Apple Watch apps and changes in the Agency's submission requirements related to Sponsor meetings,...
Innocent Until Proven Guilty: Hypothesis Test
Each of us makes important decisions that shape our lives, every day. We try to make the best decisions possible and yet, as the adage goes "all predictions of the future are wrong, some are just...
Regulatory Sciences
Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations
Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...
Quality & Compliance
Industry Poll: How Can Your GMP Auditing Program Be Most Improved
Recently, ProPharma conducted a poll to quality professionals across the country to understand the challenges that FDA regulated companies face in managing their GMP auditing programs. As depicted in...
