2018, Clinic and Manufacturing - Primary Care Digest

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).

Medical

Medical Manufacturing Healthcare Government

The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

Manufacturing

Manufacturing IT Provider ER

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).

Medical

Medical Manufacturing Healthcare Government

The Future Of Vision And Eye Care

The Medical Futurist

JUNE 21, 2025

Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. The Stanford Artificial Retina Project shows great promises.

Diabetes

Diabetes Patient-Centered IT Patients

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Most of these cases have settled out of court (see, for example, Actelion Pharmaceuticals , 2018; Astellas Pharma and Amgen , 2019; Gilead Sciences , 2020). Background.

Manufacturing

Manufacturing Medical Government IT

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

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

Patients

Patients Clinic Medical Patient-Centered

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e., In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

Provider

Provider Medical Manufacturing Consulting

FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

FDA Law Blog

DECEMBER 16, 2024

All proposals underwent an initial technical, clinical, commercial, and regulatory review before receiving funding and in-kind service support. A similar support program, instead of or in combination with third party review, could be instrumental in assisting manufacturers of LDTs to validate tests and de-risk regulatory authorizations.

Consulting

Consulting Manufacturing Utilities Provider

The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing

Manufacturing Government Referral Provider

510(k) Modernization 2023

FDA Law Blog

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ).

Medical

Medical Electronics Manufacturing Utilities

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

Manufacturing

Manufacturing Provider Consulting IT

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law Blog

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. The new rule will be codified in 21 C.F.R. Part 860.

Manufacturing

Manufacturing Government Specialization IT

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

FDA Law Blog

SEPTEMBER 20, 2021

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

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

FDA Law Blog

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations.

IT

IT Medical Patient-Centered Provider

Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. Anti-Blackness, Anti-Fatness, and Food Shaming” The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. is rooted in anti-Blackness. North Atlantic Books. Harrison, D.

Community

Community Manufacturing Patients Medical

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

FDA Law Blog

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

Medical

Medical Diagnosis Healthcare Clinic

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

MARCH 2, 2023

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. I understand that it can be a hard place clinically. J Am Geriatr Soc. So that’s kind of how it first came on my radar.

Patient-Centered

Patient-Centered IT Healthcare Medical

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

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. Susan: I will share in Indiana, we actually had that as our legal model, that there was a decision making by committee up until 2018. Alex: What did it changed to after 2018? First of all, this does feel primarily like a manufactured controversy. We can work it out!

Illness

Illness IT Healthcare Patient-Centered

Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog

APRIL 7, 2025

Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.

Vaccination

Vaccination IT Manufacturing Screening

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

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Court of Appeals (again, see our post ). The pieces of major drug pricing and payment reform are falling together.

Manufacturing

Manufacturing Supply Chain Patient-Centered Utilities

Primary Care Digest

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

The Most Engaging Decision You’ll Read All Year – Five Stars

Trending Sources

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

The Future Of Vision And Eye Care

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

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

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

510(k) Modernization 2023

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

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

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

Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

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

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

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

Every Claim You Make, Every Step You Take…CVM Will Be Watching You

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

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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