FDA Law

JUNE 27, 2023

James’s status as a 15-year champion for bringing patient voices to the table with FDA and industry decision-makers was also considered. James is recognized as helping fundamentally shift the culture to consider the patient voice as an integral part of drug development.

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Manufacturing Management Patients Provider 81

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

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. User facilities are not required, but have been encouraged, to submit MDRs electronically.

Electronics 59

Electronics Manufacturing Provider Medical 59

FDA Law

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. As we have blogged about extensively over the years, FDA has initiated, but not completed, many efforts through different means to create a regulatory framework for LDTs.

Manufacturing 59

Manufacturing Clinic Screening Healthcare 59

FDA Law

JULY 8, 2025

On June 23, 2025, FDA updated its CDER Nitrosamine Impurity Acceptable Intake Limits webpage to permit manufacturers and sponsors more time to submit required changes for nitrosamine drug substance‑related impurities (NDSRIs) for approved or currently marketed products. Such action would provide little public benefit.

Supply Chain 59

Supply Chain Manufacturing Provider IT 59

FDA Law

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

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Medical Electronics Manufacturing Utilities 64

FDA Law

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background.

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Manufacturing Patient-Centered Healthcare Utilities 83

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

NOVEMBER 7, 2021

Kirschenbaum — On September 30, we blogged about the ongoing dispute and litigation around the use of contract pharmacies under the 340B Drug Discount Program (click here ). By Faraz Siddiqui & Alan M. Last week, the U.S. District Court for the Southern District of Indiana decided several substantive motions in Eli Lilly & Co.

Manufacturing 52

Manufacturing IT Provider Patients 52

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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Manufacturing Engineering Clinic Provider 45

FDA Law

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. million).

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law

OCTOBER 9, 2023

We previously blogged about this lawsuit last year. To help patients afford the copays and deductibles for specific medications, some drug manufacturers offer direct financial assistance, often as coupons, to subsidize the patient’s purchase of the drug at the point of sale.

Insurance 40

Insurance Manufacturing Patient-Centered Individual 40

FDA Law

MARCH 31, 2024

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing the hearing, made their views clear: “FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input.

Patients 64

Patients Provider Medical Manufacturing 64

FDA Law

MAY 3, 2021

We thought this would be a good time to post a series of blog posts focusing on DEA inspections and how registrants should prepare for and manage them, with a list of registrant do’s and don’ts. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. On Commerce, Manufacturing and Trade of the H.

Management 52

Management Manufacturing Specialization IT 52

FDA Law

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S.

Manufacturing 76

Manufacturing IT Medical Provider 76

FDA Law

OCTOBER 2, 2024

A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance has not yet been finalized. Draft Guidance at 34. Comments on the Draft Guidance may be submitted until November 20, 2024.

Medical 59

Medical Specialization Manufacturing IT 59

FDA Law

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Medical information about a patient.

Clinic 52

Clinic Medical Provider Patients 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

MAY 3, 2021

We thought this would be a good time to post a series of blog posts focusing on DEA inspections and how registrants should prepare for and manage them, with a list of registrant do’s and don’ts. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. On Commerce, Manufacturing and Trade of the H.

Management 40

Management Manufacturing Specialization IT 40

FDA Law

SEPTEMBER 21, 2022

This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). Finally, the policy emphasizes the importance of validation data, and states that FDA is providing EUA templates. academic medical center laboratories).

Manufacturing 52

Manufacturing Diagnosis Diagnose IT 52

FDA Law

MAY 25, 2022

As a result, fewer generic drug manufacturers are likely to make the significant investment needed to challenge patent estates on expensive brand-name drugs, even when those challenges could have been successful or resulted in favorable settlements. The new action-packed and data-driven report has three primary sections.

Manufacturing 40

Manufacturing IT Patients Provider 40

FDA Law

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. For cell therapy products, the draft guidance notes that in vivo imaging techniques provide certain advantages.

Clinic 59

Clinic Provider IT Electronics 59

FDA Law

FEBRUARY 4, 2022

Richardson — FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”). We anticipate this being our first of several blog posts on the Proposed Rule and its potential implications in the coming weeks. By Karla L. Palmer & Kalie E.

Supply Chain 40

Supply Chain Manufacturing Provider IT 40

FDA Law

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. In addition, similar to what was required for an EUA, sponsors should evaluate cybersecurity of their system to ensure user and patient safety in the intended use environment.

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Specialization Clinic Provider IT 40

FDA Law

JUNE 7, 2023

Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs. In this case, the Supreme Court provided greater clarity on how to interpret that requirement.

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Government Patient-Centered Manufacturing IT 40

FDA Law

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

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IT Education Utilities Patient-Centered 40

FDA Law

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).

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Manufacturing Management Clinical Practice Medical 105

FDA Law

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 64

Manufacturing Physicals Provider Electronics 64

FDA Law

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however.

Manufacturing 64

Manufacturing Clinic IT Vaccination 64

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

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Medical Diagnosis Healthcare Clinic 53

Common Sense Family Doctor

FEBRUARY 15, 2025

In 1998, a Letter to the Editor in American Family Physician expressed concerns about the relatively new practice of pharmaceutical advertising directly to patients. The ad states that patients may pay as little as $5 per dose, 4 times per year.… Who could blame a patient for believing the drug doesn’t cost much.

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Family Physician Manufacturing Families Family 40

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.” The task force facilitates communication between device manufacturers and payors.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. Just like it was over a decade ago in Pliva v.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law

SEPTEMBER 8, 2022

Wasserstein — Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. The patient, on the other hand, is no closer to meeting their deductible than before.

Insurance 83

Insurance Patients Manufacturing Patient-Centered 83

FDA Law

OCTOBER 14, 2022

For medical devices, FDA noted in the 2021 December draft guidance (see here ) that it will provide 180 days advanced notice before terminating the EUA declaration. We previously blogged on this guidance document here. FDA provides FAQs about what happens to EUAs when a public health emergency ends (see here ).

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