FDA
28th October 2014

AdComm Roll Call – Spotlight on Pharmaceutical Science & Clinical Pharmacology

The FDA’s Pharmaceutical Science & Clinical Pharmacology Advisory Committee is an influential part of the FDA as it provides recommendations.

AdComm Roll Call – Spotlight on Pharmaceutical Science & Clinical Pharmacology

The FDA’s Pharmaceutical Science & Clinical Pharmacology Advisory Committee is an influential part of the FDA as it provides recommendations to the Commissioner of Food and Drugs involving scientific and technical issues regarding the safety and effectiveness of drug products for use in the treatment of a broad spectrum of human diseases. Additionally, the Pharmaceutical Science & Clinical Pharmacology Advisory Committee provides advice on the quality characteristics which drugs are purported to have, and as required, any other product for which the Food and Drug Administration has regulatory responsibility. This committee may also review Agency sponsored intramural and extramural biomedical research programs in support of FDA’s drug regulatory responsibilities and its critical path initiatives related to improving the efficacy and safety of drugs and improving the efficiency of drug development.

There are 14 voting member positions including two chairpersons. These members and chairpersons who are knowledgeable in a variety of fields which include pharmaceutical sciences (pharmaceutical manufacturing, bioequivalence research, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, molecular biology, immunology, microbiology) and clinical pharmacology (dose-response, pharmacokinetics-pharmacodynamics, modeling and simulation, pharmacogenomics, clinical trial design, pediatrics and special populations and innovative methods in drug development), biostatistics, related biomedical and pharmacological specialties, current good manufacturing practices, and quality systems implementation. 

The Pharmaceutical Science & Clinical Pharmacology Advisory Committee has not had any meetings during 2014 thus far. However, there were three scheduled for 2013; two of which were cancelled. 

A meeting on September 25th of 2013 was held to discuss the optimal strategies for the evaluation, interpretation, and communication of drug-drug interaction (DDI) information. During this meeting, the FDA sought input on: (1) best practices in DDI communication through prescription drug product labels (i.e., “package inserts”), namely: a) appropriate format for presentation (e.g. tables, graphs, text) of DDI information; b) level of detail of DDI study results; and c) appropriate wording for clinical recommendations based on empirical data vs. anticipated interactions; (2) appropriate criteria for determining whether or not to describe DDI information derived from the literature in product labels; and (3) how package insert information on DDIs is used by various end-users (e.g., prescribers, dispensers, DDI database curators) in decision making and/or communication. During this meeting, there were four discussion questions and no voting questions.

Are you interested in seeing what YOU can do to make your FDA meeting as successful as it can be? Download “ISS’ Roadmap to Advisory Committee Meeting Success!” by clicking on the button below! 

Roadmap to AdComm Success

 

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us