FDA Law Blog

NOVEMBER 27, 2023

the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers. The government charged these individuals with conspiracy (18 U.S.C. § See 15 U.S.C. § 2070. Now, fifteen years later, on Nov. It involved Gree Electric Appliances Inc.

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FDA Law Blog

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

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The Medical Futurist

JUNE 21, 2025

The situation today is as follows: One company manufactures software for the radiology department which use a certain format of AI in their daily work. No single company will come up with such software because they don’t have access to the AI data developed by individual companies.

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FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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FDA Law Blog

AUGUST 26, 2021

In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer.

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FDA Law Blog

NOVEMBER 29, 2023

Risk-based This guiding principle ensures risk management principles are used to evaluate the individual and cumulative changes over the life of the device. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change.

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FDA Law Blog

AUGUST 23, 2022

The study represents the most robust attempt at understanding the performance of serial use of rapid antigen tests for SARS-CoV-2 detection among asymptomatic individuals in the U.S. The low viral loads were most likely due to individuals infected with the Omicron variant. See our previous post on the topic here.)

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FDA Law Blog

FEBRUARY 13, 2025

Modifications to previously authorized PCCPs can be submitted via a Special 510(k), and eSTAR recommends that the manufacturer submit a clean copy and redline of the PCCP as an attachment. Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

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FDA Law Blog

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

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FDA Law Blog

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance.

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FDA Law Blog

FEBRUARY 9, 2024

Drug or biologic sponsors should engage with manufacturers of DHTs to ensure appropriate evidence has been established for the DHTs before use in a clinical study. Whereas if the DHT meets the device definition and is used outside of a clinical investigation, full compliance with design controls requirements is applicable.

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Imperial Center Family Medicine

JUNE 2, 2025

The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. The Liver & Gallbladder: Control Centers for Cholesterol Before reaching the bloodstream from food or internal production, cholesterol must first travel through the liver, the body’s primary cholesterol processing hub.

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My Green Doctor

MAY 3, 2025

operating rooms is regulated by the individual states; changing to multi-dose eyedrops will require administrative and legislative advocacy by eye specialists in every state and country. The product manufacturers and vendors will need to be active partners as well. The use of medications in U.S.

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FDA Law Blog

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021.

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FDA Law Blog

FEBRUARY 21, 2024

It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. It also specifies that manufacturers document the Unique Device Identifier (UDI) for each medical device or batch of medical devices in accordance with Part 830, Unique Device Identification.

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FDA Law Blog

NOVEMBER 14, 2022

The facility fee applies to a single manufacturing facility. The guidance explains that a facility counts as a single facility subject to a single facility fee if it is under one management and in one geographic location and address, and is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug product.

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FDA Law Blog

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

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CDOCS

JUNE 23, 2021

& A core file is then returned to design and manufacture the bridge.& & A core file is then returned to design and manufacture the bridge.& A three-unit zirconia bridge was designed and manufactured (image 14).& & The scans are sent via the Connect software to Dentsply Sirona Implants.&

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FDA Law Blog

JULY 25, 2023

Nitrosamines are chemicals that can form during drug manufacturing, known by their scientific names as N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Meanwhile, manufacturers are on the hunt to find their quarry before their customers do it for them.

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FDA Law Blog

OCTOBER 6, 2022

Lewis, Senior Regulatory Device & Biologics Expert — On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls. vector manufacturing for a transgene vector).

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FDA Law Blog

JANUARY 16, 2025

While HPM prides itself on being the largest dedicated FDA law firm in the United States, it is small by design, so it is the quality of each of these individuals and what they contribute to the firm that is most exciting, said HPM managing Director J.P.

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FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”.

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FDA Law Blog

DECEMBER 12, 2023

Acknowledging concerns about urolithiasis, pet food manufacturers use a range of formulation strategies to make UTH cat food, which have included limiting the magnesium content or formulating it to produce slightly acidic urine. Upper bound of 95% CI ≤ 2.5 CaOx: Mean RSS ≤ 6.0;

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FDA Law Blog

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year.

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FDA Law Blog

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). At the center of Pfizer’s argument is whether an AKS violation requires corrupt intent. Background.

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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?

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FDA Law Blog

APRIL 22, 2024

While FDA recommended rescheduling to schedule III, we think it more likely that if DEA reschedules marijuana it would be to schedule II because the Single Convention still requires manufacturing quotas for cannabis (which are not required for schedule III substances under the CSA). 811(d) and U.S.

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FDA Law Blog

JULY 20, 2021

FTC received more than 700 comments in response to the notice of proposed rulemaking from individuals, industry groups, consumer organizations, and members of Congress. listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America). The final rule was published on July 14, 2021.

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FDA Law Blog

JUNE 22, 2023

As a result, novel IVD manufacturers are more likely to start with clearance of a prescription test intended for use in clinical settings with the thought that one day in the future, after several years of clinical experience demonstrating safe use, they may return to FDA to seek clearance of an OTC version.

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FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? FDA has already approved the patient labeling in connection with each individual manufacturer’s PMA approval. No doubt, if FDA persists, some manufacturers may be unable to resist the pressure.

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FDA Law Blog

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. Instead, the exemption from the NTL criteria now applies to an individual food, or a mixed product that is comprised of one or more of the foods recommended by the DGs (i.e.,

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Individual Manufacturing Provider IT 52

FDA Law Blog

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection.

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FDA Law Blog

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. PFI has noted that it is not feasible to develop and label products for an individual state.

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Georgetown Pediatrics & Family Medicine

MAY 11, 2022

Purchase from well-recognized distributors, grocers, and pharmacies rather than individually sold or auction sites. Always mix formula as directed by the manufacturer. Check smaller stores and drug stores, which may not be out of supply when the bigger stores are. If you can afford it, buy formula online until store shortages ease.

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FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

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My Green Doctor

MAY 3, 2025

operating rooms is regulated by the individual states; changing to multi-dose eyedrops will require administrative and legislative advocacy by eye specialists in every state and country. The product manufacturers and vendors will need to be active partners as well. The use of medications in U.S.

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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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