Government, Information, Manufacturing and Patients

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

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

Medical

Medical Manufacturing Healthcare Government

Second Circuit Decision A Reminder that Alleged FDCA violations don’t always equal FCA violations

FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

Manufacturing

Manufacturing Government Healthcare Management

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

FDA Law Blog

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. Greater scrutiny of RUO products and those companies that manufacture them could be one of those doors.

IT

IT Manufacturing Government Clinic

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

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

Medical

Medical Manufacturing Healthcare Government

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

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

News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

FDA Law Blog

MARCH 1, 2023

The purpose of these two pilot programs was initially to inform development of a FDA rating system to characterize the QMM of a facility. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs). FDA staff served as pilot program observers, but also met with the contractors to provide feedback.

Management

Management Manufacturing Supply Chain Provider

ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law Blog

MARCH 6, 2024

More information about the conference can be found here. His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. For complete information on the conference, click here.

Management

Management Manufacturing Government Specialization

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

FDA Law Blog

SEPTEMBER 6, 2022

Below we outline the Draft Guidance and highlight the new information in the 2022 Draft Guidance. For this last question, FDA explains that it anticipates the sponsor would charge the patient directly or would charge a payor if reimbursement were available, but clearly states that FDA has no authority in this arena.

Clinic

Clinic Manufacturing Patients IT

Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Physicians had ultimate control and exercised independent judgment over their patients healthcare decisions. Mallory , 988 F.3d 3d 730 (4th Cir. Medicare or Medicaid).

Referral

Referral Relationship Government Healthcare

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic

Clinic Medical Provider Patients

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. On Commerce, Manufacturing and Trade of the H. This ensures that every non-practitioner registrant is inspected periodically.

Management

Management Manufacturing Specialization IT

Ask and Ye Shall Receive, But Don’t Ask FDA for a Virtual Inspection

FDA Law Blog

APRIL 14, 2021

Ask and ye shall receive, if yer requests are vocal and repeated, and ye are patient, and willing to accept less than ye ask for. For more than a year we have been asking FDA to initiate virtual or remote inspections of drug manufacturing facilities. business days,” the same deadline set for responding to a Form 483.

Manufacturing

Manufacturing IT Provider Government

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. On Commerce, Manufacturing and Trade of the H. This ensures that every non-practitioner registrant is inspected periodically.

Management

Management Manufacturing Specialization IT

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 maintains a database for recalls of FDA-regulated products based on information gathered from press releases and other public notices. “It It is critical for firms in a product distribution chain to be “recall ready.””.

Electronics

Electronics Manufacturing Provider IT

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law Blog

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).

Manufacturing

Manufacturing Management Clinical Practice Clinic

Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

FDA Law Blog

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 PCR, nor will they perform as well in patients with a low viral load. The sponsor must gather the requested information and cycle through with a brand new EUA filing. Why is that? Background.

Screening

Screening Healthcare Manufacturing IT

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

FDA Law Blog

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

Medical

Medical Diagnosis Healthcare Clinic

All Too Few (Two Year Version) or Where Have All the COVID Tests Gone?* A Review of FDA’s Policies

FDA Law Blog

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. The strict data requirements for tests intended to be used with asymptomatic patients led to a lack of tests available for that use. The situation now, of course, is very different and much more favorable than two years ago.

Manufacturing

Manufacturing IT Government Medical

All Too Few (Two Year Version) or Where Have All the COVID Tests Gone?* A Review of FDA’s Policies

FDA Law Blog

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. The strict data requirements for tests intended to be used with asymptomatic patients led to a lack of tests available for that use. The situation now, of course, is very different and much more favorable than two years ago.

Manufacturing

Manufacturing IT Government Patients

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

Manufacturing

Manufacturing Vaccination Government Diagnosis

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. And that’s a good thing to share with an older patient or client that making decisions about your activity. They can save a lot of money.

Healthcare

Healthcare IT Education Community

Arsenicum album for Kerala school students: a bogus prophylaxis

Tiny Physician

OCTOBER 17, 2021

The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. The whole world is going through the sequelae of economic breakdown caused due to COVID 19 and governments are facing a shortage of funds.

Vaccination

Vaccination Government IT Physicals

Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. 3, the Elijah E. 8126 with a lower MFP.

Manufacturing

Manufacturing Insurance Government Patients

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law Blog

FEBRUARY 20, 2025

Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients.

Patient-Centered

Patient-Centered Consulting Government Clinic

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. In 2021, the U.S.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

Court Strikes Down CMS’s Accumulator Adjustment Rule That Threatened Manufacturer Patient Savings Programs

FDA Law Blog

MAY 19, 2022

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C. See 42 C.F.R. §§ 447.505(c)(8)-(12).

Manufacturing

Manufacturing Patients Insurance Government

“Radical Transparency” and “Deregulation” from Trump and RFK Jr.’s FDA. Unless it’s Useful to the Device Industry

FDA Law Blog

MAY 23, 2025

Newberger Last week, FDA published a Request for Information (RFI) ( here ) seeking input from the public on its efforts to to identify and eliminate outdated or unnecessary regulations. It is therefore surprising that nearly a month or more has passed for four of these five de novos without any information being posted. By Allyson B.

Manufacturing

Manufacturing Specialization IT Provider

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law Blog

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. Information related to the importation (e.g., See 21 C.F.R. 251.5; § 251.6(c).

Supply Chain

Supply Chain Manufacturing Chronic Condition Government

Even with Short-Term Health Insurance, his Colonoscopy Bill was $7,000

Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. The fact that short-term plans can cover fewer services, conditions, and patients is why they are generally less expensive than an unsubsidized ACA plan. Capitol, and at the White House.

Insurance

Insurance Screening Hospital Patient-Centered

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

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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

Second Circuit Decision A Reminder that Alleged FDCA violations don’t always equal FCA violations

Trending Sources

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

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

The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

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

News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

Ask and Ye Shall Receive, But Don’t Ask FDA for a Virtual Inspection

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

Are You Recall Ready? FDA Expects You to Be

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

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

All Too Few (Two Year Version) or Where Have All the COVID Tests Gone?* A Review of FDA’s Policies

All Too Few (Two Year Version) or Where Have All the COVID Tests Gone?* A Review of FDA’s Policies

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

Arsenicum album for Kerala school students: a bogus prophylaxis

Drug Pricing Reform Gathers Steam (Part 2)

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

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

Court Strikes Down CMS’s Accumulator Adjustment Rule That Threatened Manufacturer Patient Savings Programs

“Radical Transparency” and “Deregulation” from Trump and RFK Jr.’s FDA. Unless it’s Useful to the Device Industry

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

Even with Short-Term Health Insurance, his Colonoscopy Bill was $7,000

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

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