lunes, 10 de agosto de 2026
The promise of radiopharmaceuticals smacks into safety concerns Excitement about the cancer treatments persists, but companies are confronting new challenges
https://www.statnews.com/2026/08/10/radiopharmaceuticals-clinical-trials-progress-setbacks/
By Allison DeAngelisAug. 10, 2026
Biotech Startups and Venture Capital Reporter
Medical Device Regulatory Expert — Hyman, Phelps & McNamara, P.C. (Washington, D.C.) August 9, 2026
https://www.thefdalawblog.com/2026/08/medical-device-regulatory-expert-hyman-phelps-mcnamara-p-c-washington-d-c/?utm_source=rss&utm_medium=rss&utm_campaign=medical-device-regulatory-expert-hyman-phelps-mcnamara-p-c-washington-d-c
Hyman, Phelps & McNamara, P.C., the nation’s premier law firm dedicated exclusively to FDA and healthcare regulatory law, is seeking an experienced Medical Device Regulatory Expert to join its multidisciplinary team. This is a unique opportunity for a seasoned regulatory professional to apply technical and strategic expertise in a sophisticated legal services setting, advising medical device clients on complex premarket and postmarket matters.
Second Time’s the Charm: HRSA Revives the 340B Rebate Pilot By Abdie Santiago —
https://www.thefdalawblog.com/2026/08/second-times-the-charm-hrsa-revives-the-340b-rebate-pilot/?utm_source=rss&utm_medium=rss&utm_campaign=second-times-the-charm-hrsa-revives-the-340b-rebate-pilot
On August 3, 2026, the Health Resources and Services Administration (HRSA) published a Federal Register notice announcing a revised 340B Rebate Model Pilot Program, stating that, for a defined set of drugs, “rebates will be used instead of upfront discounts.” It is HRSA’s second attempt at a rebate pilot in just over a year, and it arrives shortly after the D.C. Circuit’s decision in Novartis v. Kennedy, which held that rebate models are permissible under Section 340B but may not be implemented without approval from the Department of Health and Human Services (HHS). HRSA’s revised Pilot is the agency’s latest effort to exercise the authority the court recognized.
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