Expert presentation services for pharmaceutical executives and their teams working to drive positive impact for patients, physicians, and investors
Joined September 2014
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Scoop: acting FDA commissioner Kyle Diamantas told rare disease nonprofits yesterday that some major changes are coming in the post-Makary era: No more career staff overrules, and expect more adcomms endpoints.news/acting-fda-co…
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FDA will, by default, require only one clinical trial to demonstrate that a product meets its regulatory requirements for safety and efficacy in most cases, according to two top officials. hubs.la/Q043N5Lt0
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FDA chief Marty Makary says 'everything should be over the counter' unless drug is unsafe or addictive cnb.cx/4aFks2s
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EMA, FDA issue joint AI guiding principles for drug developers. hubs.la/Q03-YqGC0
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Today we published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping sponsors make better use of available data and conduct more efficient clinical trials. fda.gov/news-events/press-an…
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FDA Commissioner Marty Makary says the agency remains strong despite recent turmoil in its leadership ranks, in part due to a teamwork mentality at the agency that did not exist before. hubs.la/Q03SjG3v0
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Today, the FDA announced significant actions to accelerate biosimilar development and lower drug costs for Americans. Our new draft guidance proposes major changes to simplify biosimilar studies and reduce unnecessary clinical testing. More affordable treatment options are coming. fda.gov/news-events/press-an…
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📢 Calling all rare disease drug innovators! FDA wants your feedback on CDER’s LEADER 3D initiative – our educational platform for rare disease drug development. What’s helpful? What’s missing? Let us know!
🔗 Share your voice here: shareyourvoice.ideascalegov.…
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🚨 Our second annual AI Day is officially open for registration
We're going bigger this year in NYC, with more live programming followed by a networking reception.
Only 125 seats available & filling up now. If you're coming, don't wait: events.endpoints.news/aiday2…
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In June, FDA said an unspecified number of drug developers will be eligible for a pilot of a new National Priority Voucher program. This week, FDA said it will select up to 5 drugmakers to for the pilot and offered new details about the program’s terms. hubs.la/Q03y-hMl0
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Companies aligned with U.S. national priorities can now submit statements of interest for participation in the Commissioner’s National Priority Voucher (CNPV) pilot program. Statements of interest are capped at 350 words! More details here: FDA.gov/CNPV
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FDA has kicked off the reauthorization process for the eighth iteration the Prescription Drug User Fee Act (PDUFA VIII), with FDA Commissioner Marty Makary saying he would like to see lower fees paid by industry this time around. hubs.la/Q03xgfrZ0
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FDA publishes 200 complete response letters in transparency effort. hubs.la/Q03wRpM-0
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FDA invites you to attend a public workshop on the development of interchangeable biosimilar products. Register here for virtual or in-person participation: fda.gov/industry/fda-public-…
ALT Advertisement for an FDA Public Workshop on September 19, 2025, focusing on the future needs for the development of interchangeable products, featuring illustrations of a medical vial and a syringe.
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Corrigan-Curay announces retirement from CDER. hubs.la/Q03tlkPx0
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NEW: @US_FDA alum Mike Davis to rejoin agency as deputy director of the drug center. He previously worked in CDER's psychiatry division and most recently worked at a nonprofit developing psychedelic drugs for depression subscriber.politicopro.com/a…
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FDA announces new voucher program for drugs tied to national priorities. hubs.la/Q03sCJ5x0
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New FDA voucher pilot (Congress has yet to reauth the rare pediatric PRVs...) has a lot of flexibility on what drugs can win a voucher - but 2-yr expiration date for new vouchers really only benefits larger companies with new drugs ready to submit fda.gov/news-events/press-an…
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FDA Commissioner Marty Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research, outlined agency priorities in a JAMA Viewpoint article: hubs.la/Q03rYrLX0
