The Reproductive Health Drugs Advisory Committee (RHDAC) is a panel composed of FDA appointed members who review and evaluate data on the safety and effectiveness of human drugs for use in the practice of obstetrics, gynecology, and related specialties.
The Reproductive Health Drugs Advisory Committee (RHDAC) is a panel composed of FDA appointed members who review and evaluate data on the safety and effectiveness of human drugs for use in the practice of obstetrics, gynecology, and related specialties. There are hundreds of drugs currently on the market in these specific categories, and the impact of these drugs on women’s health makes RHDAC meetings a popular setting for debates of public opinion.
RHDAC consists of a core of 13 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics and related specialties. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, non-voting member(s) may be selected to join the committee who identifies with industry interests.
RHDAC has met three times so far in 2013. One of the meetings, for the new drug application (NDA) 022506, gabapentin 600 mg tablets submitted by Depomed, resulted in a majority vote against the approval of gabapentin for treating moderate to severe vasomotor symptoms (VMS)
due to menopause.
Want to learn more about the effects of negative AdComm outcomes?
The other two meetings held this year; Miacalcin (calcitonin salmon) injection and Miacalcin nasal spray, submitted by Novartis Pharmaceuticals Corporation, and the new drug application (NDA) 22219 for AVEED (testosterone undecanoate) intramuscular injection, submitted by Endo Pharmaceutical Solutions, Inc resulted in split outcomes.
Innovative Science Solutions has provided support for sponsors participating in numerous meetings of the RHDAC, including the recent Miacalcin AdComm. A common thread in RHDAC meetings is a conversation related to the need for providing more treatment options for women, and the meetings ISS has assisted with were no different. ISS’ experience with this particular AdComm sets us apart from others, as we understand the multifaceted issues that come into play at these meetings, especially issues related to women’s health. It is this experience that allows us to provide high quality insight into preparing for these issues and tackling them head on.
Subscribe to our blog to read our monthly roll call – who’s who on the drug advisory committees. Also stay tuned for next month’s spotlight – the Drug Safety and Risk Management Advisory Committee!
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact email@example.com.
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
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
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
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
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 todayContact us