FDA Law

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law

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 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). It was also helpful to hear first-hand the practical challenges companies navigate in bringing products to market.

Patient-Centered 40

Patient-Centered Insurance Manufacturing Provider 40

FDA Law

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

FDA Law

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. Fourth, the inability to manage this influx will harm the diagnostic industry, including manufacturers of distributed IVD products. 13, 2023), [link].

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

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.” Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law

JANUARY 18, 2024

FDA’s Center for Drug Evaluation and Research Controlled Substances Staff conducts the scheduling analysis and makes recommendations. whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. 21 U.S.C. § 802(16)(A).

Medical 69

Medical Physicals IT Healthcare Professional 69

FDA Law

MAY 21, 2024

Scientific Evidence of Marijuana’s Pharmacological Effects, If Known HHS found that marijuana abuse can lead to negative consequences that include addiction and the need for medical attention through poison center calls or emergency room visits. Basis at 18; NPRM at 44,605. Basis at 24. NPRM at 44,607. Basis at 7-8; NPRM at 44,614.

Physicals 69

Physicals Medical Clinic Emergency Room 69

FDA Law

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. Department of Justice counsel strongly defended the rule throughout the hearing.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

FDA Law

NOVEMBER 8, 2022

Torres also shared that the eSTAR program, which we most recently blogged about here , is being developed with Health Canada. To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Medical 59

Medical Manufacturing Patient-Centered Provider 59

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98