Which Regulatory Path Should I Choose for FDA Combination Products?

With FDA Combination Products on the Rise, a Common Question is, “Which regulatory path should I choose?”

What is a Combination Product? In a world in which we are continuously challenged to operate more efficiently and immersed in rapid technological advances, it should come as no surprise that one of today’s fastest growing medical product segments are combination products. To be considered a combination product by FDA, there must be two or…

QMS Risk Management

Do I Need a Medical Device Consultant to Review My Quality Management System (QMS) and/or Help with My 510(k) Submission?

What is a Quality Management System (QMS)? As a marketer or manufacturer of medical devices, you know that a quality management system (QMS) is critical to your success and continued operation. It doesn’t take more than one FDA inspection to figure this one out. If you are involved in, or considering entry into the medical…

FDA Expedited Programs

FDA Expedited Programs for Drug Development and Review, Explained

It has been my experience that even the most experienced drug development and pharmaceutical consultants will stumble over the definitions of, and differences between FDA’s four expedited programs. Included among them are accelerated approval, priority review, fast track, and breakthrough therapy.[1] This paper is designed as a primer to increase understanding of the expedited programs,…

Do you know when to use the FDA Pre-Submission Program?

Do you know when to use the FDA Pre-Submission Program?

You just designed the greatest, cure-all class II medical device of all time! Terrific! Now what? Just go to the FDA website, follow the step-by-step procedures for submitting a “traditional” 510(k), submit, and cross your fingers, right? Not so fast! You have reached a critical point in terms of strategic development considerations. You could try…

Generic Drug Consulting More Relevant Now Than Ever

Generic Safety Surveillance, Pharmacovigilance and Labeling Consulting Could Be More Relevant Now than Ever

PDG™ is comprised of pharmaceutical consultants who devote considerable resources to brand and generic post-marketing safety surveillance, pharmacovigilance and labeling supplements. On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using the Changes Being Effected (CBE) and Prior-Approval Supplement (PAS) procedures (among…

Pharmaceutical Consultant on Adaptive Design Clinical Trials in 2016

Pharmaceutical Consultant on Adaptive Design Clinical Trials in 2016

What is an Adaptive Clinical Trial? Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design. Gaining in popularity since the early 1990s,[1] adaptive trials are those which observe patient outcomes after review of interim data and accommodate modifications to trial and/or statistical procedures.[2] [3] [4] Compare such trials…

Florida Based Medical Device Consultant on 510(k) Submissions

Florida Based Medical Device Consultant on 510(k) Submissions

As a medical device consultant, PDG takes great interest in the ever-changing landscape of the premarket notification (510(k)) review and clearance process.  Besides the significant scrutiny given to the program over the past five years, the vast majority of legally marketed medical devices in use in the U.S. today were cleared via the 510(k) regulatory…

Pharmaceutical Consultant’s Update on Smoking Cessation and Generic Drug Safety Surveillance

As pharmaceutical consultants with a long history of work in smoking cessation and safety surveillance, PDG® is monitoring two pending proposed rules with great interest. The first is entitled Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations…