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Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law Blog: Biosimilars

Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.

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Upcoming Webinar on July 29: Avoiding Common Pitfalls During FDA Inspections

FDA Law Blog: Biosimilars

While the details of the expanded program are vague, this is a good opportunity for stakeholders across FDA-regulated industries around the world to ensure they are inspection ready. Richardson will be participating complimentary webinar on Avoiding Common Pitfalls During FDA Inspections. On July 29, 2025, ProPharma and HPM’s Kalie E.

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The Booming Biosimilar Market of 2020 (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Drug Channels Outlook 2021. Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. The biosimilar market is finally beginning to fulfill its promise. Drug pricing perceptions always seem to lag reality.

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JOIN HP&M FOR A WEBINAR: “The ‘End’ of the COVID-19 Emergency: The Ryan Haight Act, Telemedicine, and Next Steps?” on Thursday, March 23, 2023 at 12 Noon EST

FDA Law Blog: Biosimilars

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. Please see detailed information in the attached flyer , including a link to register for our free webinar. Hyman, Phelps & McNamara, P.C.’s We hope you join us!

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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog: Biosimilars

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.

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Replimune drug rejected by FDA; Omega raises $647M biotech fund

BioPharma Drive: Drug Pricing

Roche Chief Medical Officer Levi Garraway said the company would discuss the data with health regulators. — The observed reductions in annualized rate were about 15% in each study, but Roche noted that the total number of these “exacerbations” was lower than its scientists had expected when designing the trials.

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HP&M’s Larry Houck A Panelist in FDLI’s Marijuana Rescheduling Webinar

FDA Law Blog: Biosimilars

Director Larry Houck will participate as a panelist focusing on this timely topic in the Food and Drug Law Institute’s (“FDLI’s”) “High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling” webinar June 12, 2024, 2:00-3:30 pm ET. Information and registration is available at the conference webpage here.