FDA Law

SEPTEMBER 11, 2024

Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. For example, depending on the manufacturing process for a specific human drug, the use of some specific solvents, reagents, and catalysts may trigger the formation of these possible carcinogens.

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FDA Law

APRIL 8, 2025

DPD met all of the GDUFA commitments to publish policy documents (Section IX of the GDUFA III Commitment Letter ) and published many others the Division determined would provide clarity to the generic drug industry. Providing significant policy support to the annual update of the Orange Book Preface. 314.150(c).

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FDA Law

MAY 29, 2025

Javitt On May 8, 2025, FDA announced the successful completion of a generative artificial intelligence (AI) scientific review pilot program aimed at accelerating the review process and an aggressive timeline to rollout the use of AI tools across the Agency. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

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FDA Law

APRIL 6, 2025

2, 2025) that affirms FDAs denial of authorization to market flavored vape products. To the manufacturers chagrin, FDA squarely rejected approximately 1.2 Wages & White Lion Investments, LLC , No. 23-1038 (Apr. Following several years of delayed enforcement, FDA began reviewing a first wave of applications.

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IT Manufacturing Provider Families 59

FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents. By Steven J. Gonzalez & Allyson B. The Warning Letter seems to echo this point.

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IT Manufacturing Government Clinic 64

FDA Law

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY.

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FDA Law

NOVEMBER 16, 2021

5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). One of the new programs included in the H.R.

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FDA Law

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

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FDA Law

FEBRUARY 27, 2025

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. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.

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Manufacturing Specialization Clinic Provider 59

FDA Law

JULY 17, 2022

Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. The following example is provided in the preamble: If Part B paid a total of $1.5 million).

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Manufacturing Utilities Government Provider 52

FDA Law

MARCH 30, 2025

Livornese & Ricardo Carvajal On March 18, 2025, the U.S. Specific timelines were not provided. Encouraging Transparency : FDA is working closely with manufacturers to ensure clearer labeling and increased transparency regarding ingredients and nutritional information on formula packaging. By Charles D. Snow & Deborah L.

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Family Families Manufacturing Provider 59

FDA Law

MARCH 25, 2025

Within the Notification, FDA references a General Correspondence Letter (GCL) sent on February 26, 2025. FDA has recently issued an updated Notifications on Data Integrity Medical Devices.

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Medical Manufacturing IT Provider 59

Physician's Practice

JUNE 9, 2025

of Roetzel & Andress June 9, 2025 By Austin Littrell Fact checked by Keith A. Conclusion and Closing Remarks (00:25:02)** Thanking the guest, closing the episode, and providing subscription information. Austin Littrell June 2nd 2025 Podcast Tom Price, M.D., Austin Littrell May 19th 2025 Podcast Jeffrey A. Price, M.D.

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Management Telemedicine Patients Insurance 52

FDA Law

FEBRUARY 26, 2025

Trusting suppliers is still fundamental to any drug or device manufacturer. A 2025 study reported by Radical Compliance found that while senior management often believes in the robustness of their ethical culture, employees at other levels do not. HPM Counsel John W.M. Department of Justices Consumer Protection Branch.

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Supply Chain Management IT Manufacturing 66

FDA Law

JANUARY 2, 2025

In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025. FDA revised the rule to provide that the healthy criteria apply to individual foods with a RACC of 50 g or less, or 3 Tbsp or less, on a per 50 g basis instead of on a per RACC basis.

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Individual Manufacturing Provider IT 52

FDA Law

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). N/A June 30 The manufacturer must accept the price or counteroffer—with a rationale. CMS may respond to the counteroffer.

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Manufacturing Government IT Provider 45

FDA Law

JANUARY 5, 2025

In either case, if the consumer wrongly enters their information, e.g., and as a result obtains a drug that had they entered the information correctly, they would not have received, does that make the drug misbranded and the drug manufacturer responsible for distributing a misbranded drug? Further elaboration of FDAs view would be helpful.

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FDA Law

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law

MAY 7, 2025

On April 14, 2025, the Seventh Circuit overturned the criminal conviction of Mark Sorensen, the owner of a durable medical equipment (DME) distributor, who had been found guilty of violating the AKS. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Polin , 194 F.3d

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Referral Relationship Government Healthcare 59

FDA Law

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

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Provider Individual IT Manufacturing 52

FDA Law

OCTOBER 4, 2021

As background, FDA approved Catalyst’s NDA for Firdapse (amifampridine) for the treatment of adult Lambert-Eaton myasthenic syndrome (LEMS) and, because the product had been designated an orphan drug, awarded Firdapse the statutory 7 years of orphan drug exclusivity expiring in November 2025. 6 to less than 17 years of age).

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IT Patients Provider Manufacturing 52

FDA Law

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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Manufacturing Provider IT Electronics 105

Physician's Weekly

JUNE 18, 2025

WEDNESDAY, June 18, 2025 (HealthDay News) — On Tuesday, the U.S. Qualifying drug manufacturers must submit the chemistry, manufacturing, and controls section of their application and the draft labeling at least 60 days prior to submitting their final application. More Information Copyright © 2025 HealthDay.

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Manufacturing Clinic Provider Medical 52

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

As the 2025 legislative session swings into full gear, the Alabama Academy of Family Physicians (AAFP) has set its sights on a cadre of pivotal bills set to shape the healthcare landscape for years to come. Any contractual clause that limits or penalizes providers for sharing this information would be unenforceable.

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Insurance Management Hospital Vaccination 130

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.

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Manufacturing Management Clinical Practice Clinic 105

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.

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Manufacturing Provider Physicals Electronics 64

FDA Law

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” up to 125 total products enrolled through FY 2025). up to 60 total products enrolled through FY 2024).

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Manufacturing Medical Patient-Centered Appointment 45

FDA Law

APRIL 7, 2025

Lets take a look at these letters: Back in January 2025, CVM issued a Warning Letter to animal drug sponsor Elanco Animal Health. The omitted phrase therefore provided material facts that may be relevant to prescribing veterinarians and dog owners. that it is effective on Day 1) and insinuating misleading comparative claims.

Vaccination 64

Vaccination IT Manufacturing Screening 64

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

cases in 2024-2025, H5N1 disease in humans had a high mortality rate of up to 50%. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. Several commercial laboratories are providing this service including Quest, LabCorp, ARUP and Mayo. Prior to the current U.S.

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Patient-Centered Provider Manufacturing Screening 130

FDA Law

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. 23,711 (June 4, 2025). We think that the agency will revise and update the list more frequently as clandestine manufacturing trends require. 23,483 (June 3, 2025).

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Specialization Manufacturing Electronics PCP 69

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. that price controls distort markets and reduce competition.

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Manufacturing Government Vaccination Utilities 98

FDA Law

SEPTEMBER 14, 2021

Beginning in 2025, payment for certain “Selected” single source drugs under Parts B and D, and under commercial plans that do not opt out of the program, would be limited to a Maximum Fair Price (MFP). In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.

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Manufacturing Insurance Government Patients 52

FDA Law

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. The LDT Rule itself provides no operational guidance, but only a definition.

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GeriPal

OCTOBER 31, 2024

And because MRNA vaccine someone nimbly manufacture, they can say hey, let’s just make a vaccine based on what’s currently circulating. Among us healthcare providers who care for the elderly, I think that is a good thing to protect ourselves and our patients. Year four, year four of COVID What are you hoping in 2025, Lona?

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FDA Law

JUNE 1, 2025

The bill would also mandate that drug manufacturers report payments to influencers to the federal Open Payments database, similar to current requirements for physicians. Its unclear whether there are truly regulatory gaps that require new legislation.

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Healthcare Professional Manufacturing Healthcare Utilities 59

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.

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Manufacturing IT Individual Provider 59

FDA Law

MAY 23, 2025

The RFI reinforces Trumps January 31, 2025 executive order indicating that for every new regulation introduced, at least ten existing regulations must be eliminated (the 10for-1 Rule). The RFI is open through July 14, 2025. The Announcement raises several questions and issues for the device industry. Deregulation Efforts.

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