FDA Law Blog

SEPTEMBER 27, 2023

By James E. Valentine & Mark A. Tobolowsky — Much has changed since the long-gone days of 2017. The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.

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PEMBlog

SEPTEMBER 29, 2023

Did you know that there are comprehensive respiratory viral panels that will test for dozens of viruses all at once? Did you know that these tests are very expensive, and that they rarely alter management? Did you know that Choosing Wisely recommends that we do not routinely obtain them for respiratory viral illnesses? Of course you did, but that doesn’t mean you shouldn’t watch this entertaining video that I made with Dr.

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GeriPal

SEPTEMBER 28, 2023

Summary Transcript Summary Medical communication is tough, although fundamentally at its most basic unit of delivery, it includes really only three steps. First, a clinician’s thoughts must be encoded into words, then transmitted often via sounds, and finally decoded back to thoughts by a patient or family member. Simple, right? Not so much, as each one of these steps is fraught with miscommunication.

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FDA Law Blog

SEPTEMBER 29, 2023

By McKenzie E. Cato & Allyson B. Mullen & Gail H. Javitt — It’s the moment we’ve all been waiting for , dreading , anticipating. Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. The proposed rule has a 60-day comment period for stakeholders.

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FDA Law Blog

SEPTEMBER 26, 2023

Hyman, Phelps & McNamara, P.C. (HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Grizzel will oversee the marketing organization, with responsibility for continuing and enhancing HP&M’s brand and expanding its business development activities.

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FDA Law Blog

SEPTEMBER 24, 2023

By Faraz Siddiqui — Every parent is familiar with the parade of horrors that accompany household items as mundane as window coverings. The cords that dangle from blinds are universally recognized as a grave danger to infants and children. It is also a hot-button issue for the U.S. Consumer Product Safety Commission (CPSC), the federal agency charged with monitoring and enforcing against dangerous consumer products.

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FDA Law Blog

SEPTEMBER 28, 2023

On October 11th, Hyman, Phelps & McNamara, P.C. Director Deborah Livornese will join Faber Deaufur & Itrato Principal Jill Alvarez and Counsel Heather Centauro, and Helen Hemley at Mass General Hospital, for a discussion on diversity in clinical trials, and the implications of the new federal guidelines under the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), which was passed as part of the Consolidated Appropriations Act, 2023 , Pub.

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PEMBlog

SEPTEMBER 27, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. The Choosing Wisely Pediatric Emergency Medicine Recommendations The Choosing Wisely Campaign Toolkit Expert Contributors Olivia Ostrow, MD Hospital for Sick Children Toronto, Ontario,

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FDA Law Blog

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing. Non-compliant facilities face: Increased patient and employee health risks — in some cases even overdose deaths Multi-million-dollar settlements — and these amounts hav

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