FDA Law

JUNE 2, 2025

Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

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FDA Law

JANUARY 5, 2023

But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health. In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook.

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FDA Law

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. By Steven J. Gonzalez & Lisa M.

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FDA Law

FEBRUARY 27, 2025

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. You can access the conference brochure and sign up for the event here. And it is exactly that! As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25.

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FDA Law

AUGUST 14, 2023

It is believed that many of the inspections conducted during this period were of facilities producing essential medicines, such as COVID-related medications, for which FDA did not want to create or exacerbate product shortages. FDA also looked at how may of the Active Pharmaceutical Ingredients for those drugs were manufactured overseas.

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FDA Law

MARCH 7, 2022

At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy. Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., Copies of the guidances can be found here and here.

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FDA Law

JANUARY 2, 2023

cGMPs and other manufacturing concerns relative to products liability. Proactive adverse events monitoring and signal detection. The role of the Hatch-Waxman Act in the patenting of drugs and biologics. Clinical trials for drugs and biologics. Labeling in the drug and biologics approval process.

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FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

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FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2.

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Physician's Practice

JUNE 9, 2025

a health care attorney with Roetzel & Andress, joins the show to explore the legal risks of prescribing GLP-1 medications. 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. Adler, J.D.,

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CDOCS

MAY 4, 2021

Intra-oral photographs were taken and after reviewing his medical history we discussed his desires for a fixed replacement of these teeth. The manufacture of a screw-retained or cementable implant crown and Atlantis abutments comes with a significant cost savings. Routinely a 25-40% reduction in cost as compared to the dental lab.

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GeriPal

MAY 5, 2022

And there’s multiple survival analyses looking at incident dementia, and hearing loss is strong, independently associated with the time to event dementia. One thing we’ve looked at a little bit, but it has not been well studied is the accumulation of ototoxic medications. Five big manufacturers.

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FDA Law

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report. FDA began an initial VMSR pilot program in 2015.

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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. § 820.198).

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FDA Law

JUNE 24, 2021

Cato — On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices , which has been several years in the making. In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). By McKenzie E.

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FDA Law

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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FDA Law

MAY 15, 2025

Livornese Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institutes Annual Conference , continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. Claud & Deborah L.

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FDA Law

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

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FDA Law

JUNE 4, 2025

However, as the Assessment notes, [t]here aremany possible adverse events for which there is inadequate evidence to accept or reject a causal relationship, which may otherwise lead manufacturers to opt not to include them in the labeling.

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GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications.

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FDA Law

JANUARY 24, 2024

That’s a pretty lofty API manufacturing goal, but one that the API Innovation Center (“APIIC”) was charged to take up, consider, and propose some possible solutions. Advancements in synthetic biology realized through advanced technology can improve small molecule API manufacturing. The first goal under Theme 1—Goal 1.1—is

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FDA Law

JUNE 9, 2021

FDA also cited carbinoxamine-containing products and quinine as examples of unapproved new drugs that, due to significant adverse events, were ultimately removed from the market as a result of this program.

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FDA Law

APRIL 21, 2021

In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. Glove manufacturers affected by the exemption should beware of the likely reinstatement of the 510(k) requirements.

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FDA Law

FEBRUARY 20, 2025

In contrast, AMP and ACLA both asserted that the rule would harm medical care. Perhaps anticipating a less than favorable outcome, DOJ counsel several times asked to be allowed to submit a brief on the question of the remedy in the event of an adverse ruling. The process for gaining this alignment is through the pre-submission program.

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FDA Law

MAY 8, 2025

Claud On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. Walsh & Esther Petrikovsky & John W.M. is safe, legitimate, and honestly made. In a recent Executive Order (E.O.)

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FDA Law

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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FDA Law

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. See 21 C.F.R. 251.5; § 251.6(c). Customs and Border Protection (CBP) port of entry.

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