Pharmaceutical Development Group

Pharmaceutical Consultants and Drug Development Strategists

Over-the-Counter User Fees? OMUFA?

If the Over-the-Counter (OTC) Monograph User Fee Programme (OMUFA) is passed, it will include pre-submission meetings for proposed monograph changes....

Over-the-Counter User Fees? OMUFA?

Pharmaceutical Development Group to Attend AAPS

Pharmaceutical Development Group has announced it will be attending this year's AAPS Annual Meeting and Exposition in San Diego....

Pharmaceutical Development Group to Attend AAPS

Significant Opportunities Created by FDA in Generic Drug Development

Various changing factors in the US have resulted in the new availability of generic drug formulations....

Significant Opportunities Created by FDA in Generic Drug Development

Getting Up to Date with Complex Generics

Are you up-to-date on complex generics? You probably already know they are inherently difficult to duplicate, yet still reviewed by CDER-OGD (not CBER) using 505(j) Abbreviated New...

Getting Up to Date with Complex Generics

What is a Biosimilar and How Does it Differ Compared to Drug Development?

Prior to 23 March 2010, there was no regulatory pathway for biosimilar development in the US....

What is a Biosimilar and How Does it Differ Compared to Drug Development?

A Summary of Pharmacokinetic Principles for ANDA/505(b)(2) Submissions

As pharmaceutical consultants, the scientists at PDG are also pharmacokinetic (PK) consultants. Proper design and placement of your PK studies is critical....

A Summary of Pharmacokinetic Principles for ANDA/505(b)(2) Submissions

A Brief Summary of Seven Different 505(b)(2) Approvals

According to the guidance, a 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval 'were not conducted by or for the applicant and...

A Brief Summary of Seven Different 505(b)(2) Approvals

Types of Drug Labeling

Our most recent paper on the types of drug labeling is a useful primer for anyone with labeling or safety surveillance responsibility....

Types of Drug Labeling

How Important are Medical Device Consultants to Quality Management System Reviews and 510(k) Submissions?

Pharma consultants: Already familiar with the Quality Management System (QMS) and the benefits it has in regards to the manufacture of drugs and devices? Do you know how important it is to...

How Important are Medical Device Consultants to Quality Management System Reviews and 510(k) Submissions?

US FDA Consulting: Six Must-Read Scenarios

FDA consultants and regulatory strategists, we recognize that the space between nonprescription drugs, medical devices and prescription drugs FDA may consider ripe for Rx-to-OTC switches...

US FDA Consulting: Six Must-Read Scenarios