Sat.Jan 06, 2024 - Fri.Jan 12, 2024

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Regulatory Due Diligence Becomes More Critical in a “Hot” Year for Deals in the FDA Space

FDA Law Blog

By John W.M. Claud — As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Interest rates may be on the way down, which in turn may mean that more capital will free up and thus more deals may be in the offing.

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Episode 316: Dissecting the Learning Process with Rabih & Reza

The Clinical Problem Solvers

[link] New Year, old episode! Rabih and Reza reveal all of the math and magic behind becoming better learners. Join live morning reports here!

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Adolescent Medicine: Helping Your Teens Thrive

Family Physicians of Greeley

Adolescent medicine is a sub-specialty of family medicine and pediatrics, that focuses on the health issues of youths from ages 9 through 23. At times, the healthcare that many of these youths receive begins and ends with their yearly sports physical. And while this is a good start, thorough healthcare during these years is so much more than simply a yearly physical, including puberty, mental health, along with social and emotional development.

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What is going on with MAID in Canada? Bill Gardner, Leonie Herx, & Sonu Gaind

GeriPal

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Four percent. The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. California, which has a similar population size as Canada and legalized MAID around the same time, has fewer than 1000 deaths per year from MAID.

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“Thaw Out” with Pharma Thought Leaders at the 2024 Puerto Rico Pharmaceutical Summit: HPM Directors to Discuss Drug Approvals and Puerto Rico “Exportation” Best Practices

FDA Law Blog

Two Hyman, Phelps & McNamara, P.C. (HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. This day-long (FREE) seminar is a must-attend event for anyone in the pharmaceutical sector interested in understanding the “ins and outs” of doing business in the Territory, as well as an opportunity to interact with those who already have a keen understanding of

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Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

FDA Law Blog

By Sara W. Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). As has been explained, the BPCIA provided an abbreviated pathway to market for follow-on biologics—biosimilars and interchangeable biosimilars—and with that pathway came two types of exclusivity periods: one for the “Reference Product” to encourage continued innovation and one for the

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Why are Post-Approval Pregnancy Studies Post-Marking Requirements Rather Than Post-Marketing Commitments?

FDA Law Blog

By McKenzie E. Cato — New Year’s is often associated with baby New Year and with resolutions, which in a convoluted way got us thinking about post-approval pregnancy studies. Lots of us start the new year with a resolution. Is it a commitment, or a requirement, and does the difference matter? For post-approval pregnancy studies, it most certainly does.