Manufacturing, Presentation, Provider and Utilities

Helping FDA Help Itself: Voluntary Submissions of Allegations of Regulatory Misconduct

FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). By Véronique Li, Senior Medical Device Regulation Expert & Anne K.

Manufacturing

Manufacturing Utilities Electronics IT

Interdisciplinary Case Report

CDOCS

MAY 4, 2021

We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. & He presented with a high smile line and desired fixed natural appearing teeth.

Patient-Centered

Patient-Centered Patients Manufacturing Provider

Case Study: Six single-unit anterior crowns featuring KATANA™ multilayered Zirconia material

CDOCS

JUNE 30, 2021

A shape was chosen that provided more incisal embrasures to avoid getting the flat, worn-down look of the incisal edges (Figure 5). The multilayered block consists of four layers of zirconia in graduated shades, including an enamel layer, two transition layers and a body (dentin) layer. .

Families

Families Family Patients Manufacturing

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In this safety communication, FDA states: The U.S. 21 U.S.C. §

Patient-Centered

Patient-Centered Healthcare Manufacturing Provider

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients

Patients Clinic Medical Patient-Centered

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

FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. As such, we present these programs and initiatives roughly in order of the newest and most substantial changes to more minor.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

Are You Recall Ready? FDA Expects You to Be

FDA Law Blog

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. Almost all recalls are conducted on a voluntary basis by the manufacturer. The Guidance emphasizes that firms need to be “recall ready.”

Electronics

Electronics Manufacturing Provider IT

A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog

DECEMBER 11, 2023

FDA also does not take into account the volume of pre-submissions that laboratories will inevitably need to begin filling almost immediately after issuance of the final rule to ensure that the data they will be presenting to FDA in their premarket submissions is what the Agency will expect. of 510(k) decisions, respectively. [13]

IT

IT Medical Patient-Centered Provider

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law Blog

JANUARY 26, 2022

Speaking from a bit of experience, this has led to countless field direction memos instructing sales reps on how to pivot from their opening disease awareness presentations to their product details in an effort to keep these two types of communications separate. Creating TV commercials ain’t cheap nor is the air time for them.

IT

IT Education Utilities Patient-Centered

Will We Ever Have Widespread OTC COVID Testing in America?

FDA Law Blog

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing

Manufacturing Screening Provider Clinic

Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog

MAY 11, 2023

In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.” It’s important to note here that the Government’s brief was signed by both FDA and the USPTO.

Government

Government Manufacturing IT Utilities

Primescan Biocopy - A Valuable Resource

CDOCS

JULY 7, 2021

I diagnosed and presented him with a full mouth rehabilitation years ago, but he declined because he had his dentition restored more than once prior to becoming our patient. The opposing arch and bite were optically impressed completing all the necessary information needed to design and manufacture the case.

Manufacturing

Manufacturing Treatment Plan Provider Patients

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

AUGUST 21, 2023

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

Manufacturing

Manufacturing Consulting Healthcare Professional Vaccination

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

Commissioner Makary has taken a more subdued stance, stating in a podcast with Megyn Kelly that FDA doesnt have any plans to ban direct-to-consumer advertising, but there are some things that we can do to make sure that the information being presented is a complete picture. Healthier populations are more productive.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

Primary Care Digest

Helping FDA Help Itself: Voluntary Submissions of Allegations of Regulatory Misconduct

Interdisciplinary Case Report

Trending Sources

Case Study: Six single-unit anterior crowns featuring KATANA™ multilayered Zirconia material

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

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

Are You Recall Ready? FDA Expects You to Be

A Final LDT Rule in April!? Will FDA be prepared?

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

Will We Ever Have Widespread OTC COVID Testing in America?

Skinny Label and Induced Infringement: The Saga Continues

Primescan Biocopy - A Valuable Resource

FDA-Approved Labeling: Is Enough Enough?

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

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