Nov 26

Webinar with no image and a video. should see default thumb

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Oct 13

Another webinar with a longer title that takes more lines

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Last week, FDA and Amarin Corporation reached a negotiated settlement of a legal case concerning off-label promotion for use of a drug for an unapproved indication. The negotiation established parameters for how Amarin and the FDA will operationalize the Court’s finding that the FDA cannot stop a company from providing truthful and non-misleading information about unapproved new indications of a drug. What the Court decision and the negotiated settlement mean for the future of off-label new use promotion beyond Amarin will become clear over time. What this case prompts for me is perhaps the bigger question – and that is, how should FDA and life science companies consider the larger set of data issues that sit at the heart of our healthcare system’s transition from volume to value?

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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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Nov 15

Sample Webinar with a normal title

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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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The Center for Devices and Radiological Health (CDRH) has followed the advice of Advisory Committees to approve or not approve a product 89% of the time. Using the resources of our firm, 3D Communications, the authors conducted a survey of current and former members of FDA Medical Device Advisory Committees to determine how they prepare and the key factors that influence their thinking.

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