Physician's Weekly

JUNE 12, 2025

THURSDAY, June 12, 2025 (HealthDay News) — Some nasal and baby teething swabs from Zicam and Orajel are being recalled across the country because they may be contaminated with fungus, U.S. Food and Drug Administration (FDA) after the manufacturer, Church & Dwight Co., health officials said. The recall was announced by the U.S.

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Physician's Weekly

JUNE 18, 2025

Cost-sharing interventions and patient education can help improve access to GLP-1 receptor agonists for patients with obesity, according to an abstract presented at the AACE Annual Meeting 2025.

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FDA Law

JUNE 18, 2025

Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. Tobolowsky & Michelle L. Butler & Deborah L.

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FDA Law Blog

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 Blog

APRIL 8, 2025

Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers. This facilitated generic manufacturers access to samples of brand-name drugs not readily available through normal market channels for generic drug development.

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FDA Law Blog

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 Blog

JANUARY 14, 2025

29, 2023), a regulation for fragrance allergen labeling (statutory deadline for proposed rule June 29, 2024); and good manufacturing practice regulations (statutory deadline for proposed rule Dec. If FDA meets those deadlines, 2025 will be a busy year for both FDA and industry. Just on the cusp of 2024, on Dec.

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FDA Law Blog

NOVEMBER 16, 2021

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

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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. 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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FDA Law Blog

FEBRUARY 11, 2025

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates. The webinar will explore the legal and operational considerations for drug manufacturers.

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FDA Law Blog

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 Frustrating as that may be for the manufacturers, FDAs denial orders did not constitute a change in existing policy. Wages & White Lion Investments, LLC , No.

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FDA Law Blog

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 Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. issues with the design, manufacturing, and components of the device).

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FDA Law Blog

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. And it is exactly that!

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FDA Law Blog

JULY 17, 2022

Under the new law, Part B will continue to pay for discarded amounts from single-dose containers, but the manufacturer must pay a rebate (called a “refund”) to Medicare for discarded amounts above a specified threshold. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.

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Physician's Practice

JUNE 9, 2025

of Roetzel & Andress June 9, 2025 By Austin Littrell Fact checked by Keith A. Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. Austin Littrell June 2nd 2025 Podcast Tom Price, M.D.,

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FDA Law Blog

JANUARY 16, 2025

Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Richardson has been promoted to Director. Kalie is the quintessential HPM lawyer.

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FDA Law Blog

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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FDA Law Blog

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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FDA Law Blog

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. Department of Justices Consumer Protection Branch.

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FDA Law Blog

MARCH 30, 2025

Livornese & Ricardo Carvajal On March 18, 2025, the U.S. 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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FDA Law Blog

JANUARY 2, 2025

In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025. Therefore, manufacturers must maintain records for foods bearing a healthy claim unless it is clear from the foods mandatory labeling information. The compliance date is February 25, 2028.

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FDA Law Blog

SEPTEMBER 20, 2021

Notable Dates and Timelines – Program opens, beginning of FY 2023; Expediting reviews fully implemented, by FY 2024; Webpage with detailed criteria for acceptance and participation, October 1, 2022; Interim assessment, end of FY 2025; Public workshop, end of Q2 FY 2026. Notable Dates and Timelines – New MAPP published, by Dec.

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FDA Law Blog

OCTOBER 5, 2022

The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).

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FDA Law Blog

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 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

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.

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FDA Law Blog

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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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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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.

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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.

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FDA Law Blog

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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Physician's Weekly

JUNE 15, 2025

The samples were tested for anti-gliadin IgA/IgG antibodies using both the manufacturers and lower cut-off values.

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FDA Law Blog

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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FDA Law Blog

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. We note that CVM has issued even more enforcement actions in 2025 than on the human side: OPDP has issued 2 Untitled Letters so far in 2025 compared with CVMs 3 enforcement actions.

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FDA Law Blog

FEBRUARY 4, 2025

Koblitz Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs.

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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. To date, more than 160 million poultry are known to have been affected. Prior to the current U.S. However, the 68 human cases in the U.S.

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