FDA Law

JULY 15, 2025

One amendment would add provisions for bundled sales that are consistent with those under the Medicaid Drug Rebate Program (MDRP), with which manufacturers are familiar. Manufacturers are required to report ASP to CMS quarterly and calculate ASP for each NDC in accordance with the methodology specified by statute and CMS regulations.

Manufacturing 52

Manufacturing Consulting Provider IT 52

FDA Law

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. By Steven J. Gonzalez & Lisa M. There is no cost associated with obtaining an FEI Number.

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law

DECEMBER 12, 2023

We know what you must be thinking: “With all this crystal formation, why don’t they call them Glitter boxes?” (Apologies to our readers—word play is FDA Law Blog’s catnip.) The draft guidance provides a number of other specific recommendations on study data used to demonstrate target animal safety of the cat food. CaOx: Mean RSS ≤ 6.0;

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law

APRIL 19, 2021

We have blogged recently about several FDA setbacks in court ( here , for example). The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug.

Manufacturing 40

Manufacturing Government Medical IT 40

FDA Law

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40