Individual, IT, Manufacturing and Presentation

FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law

JANUARY 9, 2025

A foreign food manufacturer that refuses to permit entry of [FDA inspectors} to inspect such factory, warehouse, or other establishment can be subject to an import alert under section 807(b) of the FD&C Act. FD&C Act 501(j). But what exactly constitutes delaying, denying, limiting or refusing an FDA inspection?

Manufacturing

Manufacturing Management IT Medical

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3)

Manufacturing

Manufacturing Provider Medical IT

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA Law

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021.

Hospital

Hospital Manufacturing Specialization Medical

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats. Tobolowsky — Much has changed since the long-gone days of 2017.

IT

IT Manufacturing Provider Clinic

Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

FDA Law

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. It is focused on excimer lasers with premarket application (PMA) approval for LASIK in product code LZS.

Manufacturing

Manufacturing Provider Patients IT

Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

JUNE 20, 2024

Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. But then there is incontinence, which is the same term, same word, but actually presents as a geriatric syndrome. On our last podcast about urinary incontinence the song request was, “Let it go.”

IT

IT Patient-Centered Patients Clinic

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

FDA Law

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.

IT

IT Education Utilities Patient-Centered

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

CDOCS

JUNE 30, 2021

Next, following manufacturer’s instructions for use, CLEARFIL™ CERAMIC PRIMER PLUS (Kuraray Noritake) was applied to the intaglio of each restoration, followed by PANAVIA™ V5 Tooth Primer to each tooth prep, and lastly PANAVIA™ V5 Cement to the intaglio of each restoration prior to final seating.</span></p>

Family

Family Families Patients Manufacturing

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law

OCTOBER 14, 2024

The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” Defendants may also seek en banc review of the decision from the full Ninth Circuit. Robbins , 519 U.S. 452 (1997); see also Kisor v.

Clinic

Clinic Patient-Centered Asthma Patients

FDA Denies Vanda’s Citizen Petitions Regarding the Need for Braille Labeling for Tasimelteon Generics

FDA Law

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

Manufacturing

Manufacturing IT Medical Individual

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

FDA Law

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. For additional information on planning patient engagement, please see the CDRH’s Patient Science and Engagement Program. Finally, mark your calendars for the upcoming March 22, 2022 FDA webinar about this Guidance.

Patients

Patients Clinic Medical Patient-Centered

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

FDA Law

SEPTEMBER 20, 2021

As such, we present these programs and initiatives roughly in order of the newest and most substantial changes to more minor. When travel restrictions and public health precautions halt facilities inspections, many sponsors are left wondering how FDA will complete pre-approval inspections and meet their products’ respective PDUFA dates.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. They are required to present their credentials, explain the purpose of their visit, and provide a written notice of their inspection authority.

Management

Management Consulting Provider Physicals

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. They are required to present their credentials, explain the purpose of their visit, and provide a written notice of their inspection authority.

Management

Management Consulting Provider Physicals

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

FDA Law

MAY 19, 2023

Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e., analytical, clinical and stability).

Specialization

Specialization Clinic Provider IT

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

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

Manufacturing Provider Physicals Electronics

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Alex 00:59 And I met all three of you and watched you do a presentation about psilocybin research at the Congress International Desens Palliative Miguel. We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. It’s there.

Illness

Illness IT Patient-Centered Patients

Will We Ever Have Widespread OTC COVID Testing in America?

FDA Law

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

Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

MARCH 24, 2022

All decisions are made in advance, the question that we are debating is how far in advance and what to call it. Completion of advance directives and billing codes for advance care planning as quality metrics. Among other topics. We can work it out! Links to a few couple items mentioned on the podcast: Objectives for Advance Care Planning.

Illness

Illness IT Healthcare Patient-Centered

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

OCTOBER 17, 2023

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. In addition, criterion one can also apply to technologies and device features aimed at improving accessibility, defined as “an individual or group’s capacity to benefit from a medical device or procedure.”

Medical

Medical Diagnosis Healthcare Clinic

FDA-Approved Labeling: Is Enough Enough?

FDA Law

AUGUST 21, 2023

Koblitz & Deborah L. Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.” More than a few have taken far longer—literally decades.

Manufacturing

Manufacturing Consulting Healthcare Professional Vaccination

A Review of H5N1

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

There have been a few severe cases and one individual died with H5N1 infection. This influenza infection primarily presents in cattle as decreased milk production, lethargy, and decreased appetite. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

Patient-Centered

Patient-Centered Provider Manufacturing Screening

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

FDA Law

SEPTEMBER 8, 2022

Recognizing the problems that high prescription drug costs pose to patient access to medications, many drug manufacturers have created copay assistance programs to help patients afford the copays and deductibles for their medications. These prohibitions are often referred to as copay accumulator adjustment programs.

Insurance

Insurance Patients Manufacturing Patient-Centered

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

FDA Law

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. If significant progress toward MFN is not made, the EO seeks to permit personal importation of less expensive drugs from foreign countries.

Manufacturing

Manufacturing IT Provider Individual

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law

MAY 26, 2025

The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution. Late last month the Attorney General issued a memo addressing both directives. First, it direct[s] all U.S. MedImmune, Inc. Genentech, Inc.,

Manufacturing

Manufacturing Provider Medical IT

Primary Care Digest

FDA Inspections: Lesson 1 – Interviewing Employees

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

Trending Sources

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

Urinary Incontinence Revisited: George Kuchel & Alison Huang

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

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

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Denies Vanda’s Citizen Petitions Regarding the Need for Braille Labeling for Tasimelteon Generics

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

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

Will We Ever Have Widespread OTC COVID Testing in America?

Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA-Approved Labeling: Is Enough Enough?

A Review of H5N1

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

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