Preparing a New Drug Application (NDA) or Pre-Market Approval (PMA) is one of the most arduous tasks regulatory teams have to face – and thinking about a possible Advisory Committee (ADCOM) meeting at the same time may seem impossible. But approaching NDA/PMA preparation with the possibility of an Advisory Committee meeting in mind not only improves a Sponsor’s chances at an ADCOM – it could prevent one from ever happening.

Here are five tips on how to approach NDA/PMA preparation with a possible ADCOM in mind.

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For pharmaceutical or device company teams, there is one common thread for all FDA meetings: the need to tell a clear story and to set the data or issue in context. Just as FDA has a process for determining whether a drug or device should be approved, companies need a proven process to keep their team on track and prepare in the most efficient and effective way. Our process includes these seven steps.

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Following the results of the Amarin legal judgment, there has been speculation that the ability to promote unapproved, “off-label” claims for prescription drugs will dramatically change. Yet, there are specific reasons why the Amarin First Amendment legal case succeeded and hundreds, if not thousands, of other cases have failed. While the Amarin judgment has set a precedent, it should not have a dramatic change on promotional claim requirements in pharma marketing – meaning that companies do not have First Amendment protection for statements that are untruthful and misleading. It’s not expected that the FDA will diminish the criteria needed to support substantial evidence of efficacy. Instead they will continue to vigorously protect public health and the communication of accurate, science-based information.

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Many new drugs that get to market today are reviewed and approved under one of the Center for Drug Evaluation and Research’s (CDER) expedited approval pathways. In 2015, 27 of the 45 new drugs approved by the FDA were reviewed through an expedited approval pathway. These pathways were developed after criticism from patient groups during the AIDS epidemic in the 1980s that the Food and Drug Administration (FDA) took too long to approve potentially life-saving new drugs. The four main expedited pathways – Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review – offer several opportunities for Sponsors to gain expedited approval and extra incentives when submitting New Drug Application (NDA) applications for drugs intended to treat serious conditions. The programs aim to get important treatments to patients in need as quickly as possible, while still maintaining careful control over safety and efficacy.

So how exactly do these pathways work? What products are eligible for them? When do Sponsors need to apply?

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Preparing effectively for an FDA Advisory Committee meeting requires that the Sponsor team anticipate discussion and voting topics that the FDA will pose to the Advisory Committee. These discussion topics and voting questions will influence the information the team provides to the committee and the questions the committee poses to the team. A review of Advisory Committee meetings over the past five years revealed that in more than 40% of meetings, the FDA asked at least one question related to post-approval safety plans.

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Gaining regulatory approval as quickly and smoothly as possible is obviously the number one goal for sponsors as they submit their NDA, BLA, or PMA to regulatory authorities including the FDA and EMA. A regulatory submission is the one time when the data don’t speak for themselves – and it’s no time to make mistakes. The reality is that even the best sponsor teams run the risk of falling in love with their data and “drinking their own Kool-Aid.” The good news is there are ways to avoid this common pitfall.

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Recognizing the value of patient insights in drug development, FDA has made great efforts to integrate patient perspectives into its benefit risk framework for a number of disease areas through the Patient-Focused Drug Development (PFDD) program, an initiative of the Prescription Drug User Fee Act (PDUFA) V of 2012. One of the common points patients shared at the PFDD workshops held over the past two years is the feeling that their “chief complaints” or needs are not being factored into drug development plans, including measures of a drug’s benefit in clinical trials. To get an inside read on why this may be occurring and what can be done to correct it, we spoke with representatives from the Obesity Action Coalition, the IBD Support Foundation, and the Arthritis Foundation, all of whom are actively engaged in giving a voice to patients in their communities and improving access to optimal care. They shared their perspectives on how the role of patients has evolved in the past decade and what can be done in the future to better factor patients’ feedback into drug development and access planning.

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An important component of the Advisory Committee meeting is the open public hearing (OPH), normally a one-hour session reserved for the public to share opinions about and experiences with the product. The OPH can last as long as, or longer than, the sponsor or FDA presentations during an Advisory Committee meeting, yet there is little research on any potential impact it may have on the voting. This article originally appeared in Regulatory Focus in September 2015 and discusses the importance of the open public hearing portion of an FDA Advisory Committee meeting.

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It’s widely reported that the top three stresses in life are death, divorce, and moving. But pharmaceutical or device manufacturers going for product approval might add a close fourth – preparing for high-stakes presentations and meetings like an FDA Advisory Committee meeting. During intense preparations, it’s easy to lose sight of the most important thing – keeping yourself healthy,both physically and mentally. Here are some basic reminders to help you and your team reduce team stress during the ramp-up to a big event.

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