2025, Clinic, Manufacturing and Patients

Green Practice News: May 2025

My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health.

Healthcare

Healthcare Healthcare Professional Consulting Management

Researchers Propose Solutions to Improve GLP-1 RA Access

Physician's Weekly

JUNE 18, 2025

Cost-sharing and education may improve access to GLP-1 therapies for obesity, but systemic barriers remain, requiring broader policy and clinical reforms. The patient was enrolled in a cost-sharing program that reduced her out-of-pocket expenses by 70%, allowing her to access the medication.

Healthcare Professional

Healthcare Professional Insurance Manufacturing Healthcare

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

FDA Law Blog

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. Those in the lab industry and the physicians and patients who rely upon LDTs are sure to be breathing a well-deserved sigh of relief over this development. By Steven J. Gonzalez & Allyson B.

IT

IT Manufacturing Government Clinic

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

Oops!… [FDA] Did It Again: Another Orphan Drug Act Loss for FDA Based on Unambiguous Statutory Text; 11th Circuit Rules that the Scope of Orphan Drug Exclusivity is Determined by the Rare Disease or Condition Designated, and Not the Indication Approved

FDA Law Blog

OCTOBER 4, 2021

Circuit told FDA, for the second time , that the plain text of the Orphan Drug Act unambiguously required FDA to award orphan drug exclusivity to any orphan designated drug, even if that designation was based only on a “plausible hypothesis” of clinical superiority that ultimately could not be confirmed. 6 to less than 17 years of age).

IT

IT Patients Provider Manufacturing

FDA Offers Speedier Approvals to Drug Companies Aligning With ‘National Priorities’

Physician's Weekly

JUNE 18, 2025

WEDNESDAY, June 18, 2025 (HealthDay News) — On Tuesday, the U.S. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists. More Information Copyright © 2025 HealthDay. said in a statement. said in a statement. All rights reserved.

Manufacturing

Manufacturing Provider Clinic Medical

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law Blog

MARCH 6, 2025

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls. data acquisition device).

Manufacturing

Manufacturing Management Clinical Practice Clinic

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing

Manufacturing Provider Physicals Electronics

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” up to 125 total products enrolled through FY 2025). up to 60 total products enrolled through FY 2024).

Manufacturing

Manufacturing Medical Appointment Patient-Centered

A Review of H5N1

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

cases in 2024-2025, H5N1 disease in humans had a high mortality rate of up to 50%. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. The Bureau of Clinical Laboratories at ADPH is also providing testing but should be prioritized for patients that are underinsured or uninsured.

Patient-Centered

Patient-Centered Provider Manufacturing Screening

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

FDA Law Blog

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services.

Patient-Centered

Patient-Centered Consulting Government Clinic

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law Blog

JUNE 1, 2025

The Protecting Patients from Deceptive Drug Ads Online Act, co-sponsored with Senator Mike Braun (R-IN), seeks to close regulatory gaps by empowering FDA to issue Warning Letters and impose fines on social media influencers and telehealth companies that promote prescription drugs without proper disclosures of risks and side effects.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

MedTech Conference Download

FDA Law Blog

NOVEMBER 8, 2022

For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. Dr. Baron spoke to specific actions sponsors can take to improve representation of women in cardiac clinical trials.

Medical

Medical Manufacturing Patient-Centered Provider

Primary Care Digest

Green Practice News: May 2025

Researchers Propose Solutions to Improve GLP-1 RA Access

Trending Sources

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

Oops!… [FDA] Did It Again: Another Orphan Drug Act Loss for FDA Based on Unambiguous Statutory Text; 11th Circuit Rules that the Scope of Orphan Drug Exclusivity is Determined by the Rare Disease or Condition Designated, and Not the Indication Approved

FDA Offers Speedier Approvals to Drug Companies Aligning With ‘National Priorities’

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

A Review of H5N1

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

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

MedTech Conference Download

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