Manufacturing, Patients, Presentation and Utilities

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

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

Patients

Patients Clinic Medical Patient-Centered

Interdisciplinary Case Report

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

Patient-Centered

Patient-Centered Patients Manufacturing Provider

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

CDOCS

JUNE 30, 2021

Specifically, the patient stated he wanted younger-looking teeth and was tired of having the composites replaced every few years, and therefore desired an esthetic and lasting solution. Additionally, it was decided to add more incisal embrasures, as the patient was unhappy with the flat, worn down look of his natural teeth.</span></p>

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. These clearances are based on short-term (30 day) patient follow up.

Patient-Centered

Patient-Centered Healthcare Manufacturing Provider

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

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

Are You Recall Ready? FDA Expects You to Be

FDA Law Blog

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA has model recall communication templates available here that firms can utilize. Manufacturers hope for the best that their products are going to be used safely and effectively for patients and consumers.

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

Will We Ever Have Widespread OTC COVID Testing in America?

FDA Law Blog

FEBRUARY 22, 2022

We identified as the main culprit FDA’s requirement that these tests achieve 80% sensitivity (positive percent agreement or PPA) even when a required percentage of low positive patients are included. 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

Primescan Biocopy - A Valuable Resource

CDOCS

JULY 7, 2021

Having no technical nor clinical experience with the digital production of in office restorations I fabricated a crown that I glazed in Scottsdale and cemented onto my patients’ first premolar the very next Monday at my Brooklyn N. My first experience with CEREC was creating a single unit crown during a CEREC ACCEPT program.

Manufacturing

Manufacturing Treatment Plan Provider Patients

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

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

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

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

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

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

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

Are You Recall Ready? FDA Expects You to Be

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

Will We Ever Have Widespread OTC COVID Testing in America?

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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