The FDA Drug Approval Process Improved

The FDA Drug Approval Process Improved

In 2018, the FDA pledged to improve the drug approval process and the efficiency of drug development, allowing pharmaceutical development consulting firms to serve their clients more effectively. In attempt to prevent drug shortages and to increase generic drug access, the FDA is improving their drug review process. Pharmaceutical development services can be expedited due…

What is an FDA U.S. Agent?

What is an FDA U.S. Agent?

February 2, 2018: PDG® is a global pharmaceutical consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. As such, PDG is an integral part of client decision-making processes with regard to the designation of FDA U.S. Agents and Official Contacts. In addition,…

An Introduction to Clinical Trials and Resources for Continued and Intermediate Learning

In January 2018 this introduction to clinical trials was prepared by the pharmaceutical consultants at PDG who routinely design and write clinical trial protocols. This paper represents a collection of quotes and resources ranging from basic primers to more advanced concepts. This is provided for drug and medical device professionals who may not serve in…

Breaking Down Complex Generics

Breaking Down Complex Generics

What are Complex Generics? Complex generics are those that are inherently difficult to duplicate, reviewed by CDER – OGD (not CBER) using 505(j) Abbreviated New Drug Applications (ANDAs), are generally off-patent and represent markets with higher barriers to entry. According to Robert Lionberger, Ph.D. of OGD, Complex generics may be characterized by the following:[1] Complex…

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

Many of today’s most important medications are biologics. Among the notable conditions treated by biologics are rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions and various forms of cancer. As you probably perceive, biosimilars are to biologics what generic drugs are to brand-name drugs. However, there are major differences between…

Pharmacokinetics in Drug Development

Pharmacokinetics in Drug Development Related to ANDA/505(b)(2) Submissions

As pharmaceutical consultants, the scientists and regulatory professionals at PDG® design pharmacokinetic (PK) protocols for a wide variety of applications. This paper has been written to provide the reader with a basic review of pharmacokinetic and pharmacodynamics (PD) principles as well as an exposure to a cross section of the utility of PK studies. While…

Seven Noteworthy 505(b)(2) Submissions

Seven Noteworthy 505(b)(2) Submissions

As drug and device consultants, the scientists and regulatory experts at PDG® spend a considerable amount of time working on 505(b)(2) NDA submissions. This paper highlights notable features of a cross section of recent 505(b)(2) approvals and provides a variety of everyday issues to consider as you contemplate your next drug development project. Generic companies…

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…

Rx-to-OTC, OTC-to-Rx Switch, Drug-Device Combinations; Where do the opportunities lie?

Rx-to-OTC, OTC-to-Rx Switch, Drug-Device Combinations; Where do the opportunities lie? 6 MUST READ SCENARIOS

As a prescription and OTC pharmaceutical consultant, I am repeatedly amazed by the successes resulting from the simplest of drug & device development ideas. While it may be legend, it is said that Charles H. Duell, Commissioner of the US Patent Office in 1899 coined the phrase “everything that can be invented has been invented.”…