article thumbnail

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

The FDA Law Blog

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 ).

FDA 64
article thumbnail

PDURS explained: The FDA’s new framework for adding software to drug labels

pharmaphorum

In this fireside chat webinar, experts break down the FDA's new PDURS framework for adding software to drug labels. Learn how it impacts pharma and what you need to know. Join us on Tuesday 9th July @ 07:00am PDT / 10:00am EDT / 15:00pm BST / 16:00pm CEST.

Labelling 119
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

The FDA Law Blog

These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. Please see detailed information in the attached flyer , including a link to register for our free webinar. When the public health emergency ends on May 11, 2023 , so do these exemptions. We hope you join us!

article thumbnail

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

The FDA Law Blog

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.

article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. In this exclusive webinar, Dr. Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. What will the future hold for clinical research?

article thumbnail

Get Up To Speed on Medicare Inflation Rebates: HPM Issues Memorandum Summarizing CMS Final Rule; HPM and Riparian to Co-Host Webinar

The FDA Law Blog

In addition, on Tuesday, February 18, Hyman, Phelps & McNamara will be co-hosting a webinar on the CMS final rule with Riparian LLC. The webinar will explore the legal and operational considerations for drug manufacturers. Once you register, youll receive instructions by email on how to access the webinar.

59
article thumbnail

HPM’s John Claud to host webinar for FDANews: “Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.”

The FDA Law Blog

will present a webinar entitled “ Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.” On Thursday, April 20, from 1:30-3:00pm, John Claud of Hyman, Phelps & McNamara, P.C.

FDA 52