FDA Law

JULY 13, 2022

If a drug that has been approved for 12 years—but less than 16 years—is selected for the Drug Price Negotiation Program, a biosimilar manufacturer can request a one-year moratorium on negotiations for that product so that the biosimilar manufacturer has time to secure licensure and begin marketing of the biosimilar version.

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My Green Doctor

MAY 3, 2025

This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. Latest news & breaking headlines And, in many countries, governments offer financial incentives to install solar panels and even backup batteries.

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FDA Law

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.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., This guidance document is still in effect today.

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FDA Law

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.

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FDA Law

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.

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FDA Law

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

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. Medicare or Medicaid). OIG reviews non-safe harbored arrangements on a case-by-case basis.

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FDA Law

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

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Management Manufacturing Supply Chain Provider 45

FDA Law

JULY 17, 2022

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.

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Manufacturing Utilities Government Provider 52

FDA Law

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?

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FDA Law

SEPTEMBER 6, 2022

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. Authorization for Charging in the Clinical Trial Context.

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Clinic Manufacturing Patients IT 52

FDA Law

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. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation. 17, 2020.

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Management Manufacturing Specialization IT 52

FDA Law

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.

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Manufacturing IT Provider Government 40

FDA Law

JUNE 7, 2023

The cases were both brought under the False Claims Act (FCA), the Civil War-era law that the government uses to claw back funds it pays out to parties that overbill federal programs. They are entitled to receive one third of any claw back, which can result in multi-million-dollar awards. What was SuperValu all about?

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Government Patient-Centered Manufacturing IT 40

FDA Law

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. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation. 17, 2020.

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Management Manufacturing Specialization IT 40

FDA Law

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.

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Clinic Medical Provider Patients 52

FDA Law

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. Walsh — All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field. It is critical for firms in a product distribution chain to be “recall ready.””. Product coding (e.g.,

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law

MARCH 30, 2022

Karst — It was some time ago that we posted on what we though was “the Good” in an avalanche of FDA-related legislation that we sorted into three categories: the Good, the Bad, and the Ugly. 1463 ) and the “ Simplifying the Generic Drug Application Process Act ” ( S. The first of such legislative proposals targets 180-day generic drug exclusivity.

Manufacturing 40

Manufacturing IT Government Healthcare 40

The Health Policy Exchange

MAY 20, 2013

Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. Approval from the U.S. The size of average doses would more than triple.

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FDA Law

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).

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Manufacturing Management Clinical Practice Clinic 105

FDA Law

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. counter (OTC) rapid antigen tests for COVID are widespread and available at low cost. Why is that? Background. 2 infection.

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Screening Manufacturing Healthcare IT 98

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law

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.

Manufacturing 52

Manufacturing IT Government Medical 52

FDA Law

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.

Manufacturing 52

Manufacturing IT Government Patients 52

FDA Law

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.

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Medical Diagnosis Healthcare Clinic 53

FDA Law

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.

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Manufacturing Vaccination Government Diagnosis 59

GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

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FDA Law

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D.

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Manufacturing Government Vaccination Utilities 98

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. Contrary to our beliefs, the second wave came and exposed all the weaknesses of our health system. Dipankar et.

Vaccination 52

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FDA Law

AUGUST 3, 2021

Department of Health and Human Services in December 2020 to prevent Medicare Part D and Medicaid Managed Care plans from receiving rebates from manufacturers unless the rebates are passed through to pharmacies to reduce patient out-of-pocket expenses. By Faraz Siddiqui — On Monday August 2, 2021, the Senate took up for review H.R.

Manufacturing 52

Manufacturing Transportation Government Management 52

FDA Law

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.

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Manufacturing Insurance Government Patients 52

FDA Law

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.

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Patient-Centered Consulting Government Clinic 102

FDA Law

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).

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FDA Law

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.

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Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

OCTOBER 14, 2022

The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. But if you are a medical product manufacturer, the news of the termination of COVID-19 PHE could complicate your business plan. But the pandemic is over.

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Medical Manufacturing Provider Complication 98

FDA Law

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. The Announcement raises several questions and issues for the device industry.

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