The Medical Futurist

JUNE 21, 2025

Although this revolution has been brewing for years, the past few months marked a major change , as algorithms finally moved out of the specialized labs and into our daily lives. The future of medicine is undoubtedly inextricably linked to the development of artificial intelligence (AI). ” Patient points to lower abdomen.

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FDA Law Blog

OCTOBER 3, 2022

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. This lawsuit was brought to the U.S. district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action.

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FDA Law Blog

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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FDA Law Blog

MARCH 27, 2023

So, what is special about September 24, 2023? Legacy FDA identification numbers refer to both National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers created using labeler codes previously assigned to device manufacturers by FDA. Most of the compliance dates have been passed. Emphasis added.) It is not far off!

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FDA Law Blog

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

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FDA Law Blog

FEBRUARY 13, 2025

In fact, eSTAR does not allow a PCCP to be included in a Special 510(k); attempting to do so results in the message if you are establishing a PCCP this should not be done in a Special 510(k). FDA recommends including only a limited number of modifications in the PCCP.

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Georgetown Pediatrics & Family Medicine

MAY 11, 2022

Always mix formula as directed by the manufacturer. If you have any concerns about your baby’s nutrition, please talk with your pediatrician. What if baby formula is out of stock everywhere I look? Check smaller stores and drug stores, which may not be out of supply when the bigger stores are. Check social media groups.

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FDA Law Blog

OCTOBER 2, 2024

We find it surprising that a PCCP may not be submitted with a Special 510(k), given a Special 510(k) may be used to modify an existing device where well-established methods are available to evaluate the change. FDA, Guidance for Industry, The Special 510(k) Program (2019). Change Guidance at 8. Draft Guidance at 34.

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FDA Law Blog

FEBRUARY 27, 2025

As such, we can offer our readers a special 10% discount. The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. And it is exactly that! The discount code is: D10-999-FDA25.

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FDA Law Blog

MAY 4, 2025

Both chemicals are used in the illicit manufacturer of fentanyl. 1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. Both chemicals are used in the illicit manufacturer of fentanyl. By my count there have been only ten since 2000).

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Minnesota Academy of Family Physicians

MARCH 27, 2025

The Minnesota Council of Health Plans (MCHP) raised concerns, as the bill enacts new regulations on health plans, and they contend they have little control over pricing set by drug manufacturers. This will trigger a special election in District 6. The bill was laid over for possible inclusion in a future omnibus bill.

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FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. Whether HF33 is enacted or not, state legislative initiatives aimed at combatting the opioid epidemic continue to be a moving target for opioid manufacturers.

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FDA Law Blog

OCTOBER 31, 2022

It seems that FDA may have validated that, even with an Excellence Appraisal above and beyond standard compliance with good manufacturing practices, there is a need for pre-market review for Class 2 devices. We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here. Key Findings at 12.

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Imperial Center Family Medicine

MAY 26, 2025

How Cooking Oils Impact Cholesterol Before getting into specific oils, it helps to know a little about dietary fats and cholesterol. Cholesterol is a form of fat with a waxy consistency that is found in your blood. Your body needs it to construct healthy cells, but having high cholesterol can raise your risk for heart disease.

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FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law Blog

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

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FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle.

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FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The main body of the draft guidance provides high-level recommendations, and four appendices provide detailed recommendations for test design. In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

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FDA Law Blog

MAY 27, 2024

She also specializes in medical device software and digital health. She was an outstanding lawyer before, and her in-house experience will provide even greater breadth and depth of expertise to medical device manufacturers,” notes Jeffrey Gibbs, HPM Director. Hyman, Phelps & McNamara, P.C.

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FDA Law Blog

OCTOBER 25, 2021

In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. FDA says inspections may be necessary if a device has “critical and/or novel manufacturing processes that may impact the safety and effectiveness of the device.” The new rule will be codified in 21 C.F.R.

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FDA Law Blog

FEBRUARY 19, 2024

Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. While at FDA, Ms. During her FDA tenure, Ms.

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FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.

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FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.

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FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle.

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FDA Law Blog

MAY 7, 2025

Seventh Circuit ruling in Sorensen In Sorensen , the government alleged, and the District Court agreed, that Sorensen paid illegal kickbacks to marketing firms based on the number of leads generated and a DME manufacturer based on the percentage of funds collected from Medicare. Medicare or Medicaid). Polin , 194 F.3d 3d 863 (7th Cir.

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FDA Law Blog

SEPTEMBER 30, 2022

The controversy over the FCA’s intent standard where the applicable statute or regulation is ambiguous has special relevance when the FCA is used to target inaccurate government price calculations. The relator has until December 22, 2022 to petition for certiorari to the Supreme Court. of America v.

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FDA Law Blog

JUNE 7, 2023

Doing business with the federal government comes with numerous restrictions and special provisions in exchange for the benefit of having access to Federal reimbursements. According to the suit, the pharmacies improperly collected the full price for drugs from CMS that they dispensed to consumers under a discounted pricing plan.

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FDA Law Blog

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. By Larry K. Policies and Procedures. The policies and procedures should include a section on how the registrant handles DEA inspections.

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FDA Law Blog

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. By Larry K. Policies and Procedures. The policies and procedures should include a section on how the registrant handles DEA inspections.

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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FDA Law Blog

OCTOBER 30, 2023

Houck — The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. DEA’s notice of updates with the Special Surveillance List is attached here.

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FDA Law Blog

JUNE 26, 2023

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 21 U.S.C. §

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Physician's Weekly

JUNE 19, 2025

In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. He’d been taking it for years, and he expected to pay about seventy bucks. He’d have to pay more than 500 dollars. He left without it. A few days later, he had a massive asthma attack.

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FDA Law Blog

JANUARY 4, 2022

Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code. Other jurisdictions like D.C.

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FDA Law Blog

MAY 11, 2023

Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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GeriPal

MAY 8, 2025

So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. 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. Alex 02:16 Jim Low e.

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FDA Law Blog

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.”

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