FDA Law Blog

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.

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FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.

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Rethinking Clinical Trials

JANUARY 31, 2024

In this Friday's PCT Grand Rounds, Susan Winckler of the Reagan-Udall Foundation for the FDA will present "Strategies for Improving Public Understanding of FDA and the Products It Regulates: Why Should We Care, and What Might We Do?" The Grand Rounds session will be held on Friday, February 2, 2024, at 1:00 pm eastern.

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Advarra

JULY 26, 2022

Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act. The post CBD Research: A Dive into the Regulations of Cannabis Research appeared first on Advarra.

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FDA Law Blog

JUNE 14, 2021

Shapiro — In our last post on Laboratory Developed Tests (LDTs) , we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. This step would help propel forward a public conversation (which CMS has already started ) about how to update these regulations in light of technological advances.

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Cloudbyz

AUGUST 22, 2024

In the cosmetics industry, innovation is key to staying ahead of the competition. As consumer preferences evolve and regulatory demands increase, cosmetics companies are under pressure to prove the safety and efficacy of their products through rigorous clinical studies.

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FDA Law Blog

AUGUST 13, 2023

As reported previously , MOCRA includes a requirement for facility registration and listing of cosmetic products. Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities. 7, 2023.

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STAT News

MARCH 9, 2023

billion ask for the Food and Drug Administration, which includes funding specifically set aside for improving the oversight of food manufacturing, regulating cosmetics, and making the medical device supply chain more resilient. The request made Thursday also details a $7.2 Continue to STAT+ to read the full story…

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Camargo

SEPTEMBER 8, 2021

devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA. Final Regulation Issued for “Intended Use”.

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Cloudbyz

MAY 26, 2023

The cosmetics and personal care industry is one where customer trust is paramount, given that the products are applied directly to the skin, hair, and body. A well-implemented safety vigilance solution ensures that companies stay compliant with these regulations, minimizing the risk of sanctions or penalties.

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Medical Xpress

JANUARY 16, 2023

It's a riddle that's long puzzled regulators and consumers. When is a surgeon not a surgeon? But it may soon be solved.

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FDA Law Blog

AUGUST 9, 2021

Circuit , FDA published a Federal Register Notice today (August 9) soliciting comments on its proposed approach to implementing the Court’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) distinction between drugs and devices.

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FDA Law Blog

JANUARY 22, 2023

FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. The law enacts significant changes that will have considerable short- and long- term effects on the regulated industry and the FDA. 117-328 (2022). has prepared a detailed Summary and Analysis of FDORA.

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XTalks

FEBRUARY 8, 2022

Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? The list includes 30 food safety tasks that fall into several categories, including allergens, cosmetics, dietary supplements, food additives, Food Safety Modernization Act (FSMA), labeling and nutrition.

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pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

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FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).

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XTalks

SEPTEMBER 17, 2020

The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. FDA Chief Counsel Stacy Amin said in a statement , “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk.

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FDA Law Blog

DECEMBER 12, 2022

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).

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FDA Law Blog

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

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Pharma Tutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. Hyman, Phelps & McNamara, P.C. (“HP&M”)

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pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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Pharma in Brief

NOVEMBER 20, 2023

The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. Natural health product vs. regulated drug In Winning Combination Inc. In its August 16, 2023 decision in Le-Vel Brands, LLC v.

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FDA Law Blog

SEPTEMBER 30, 2021

See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2). Section 503A’s language requires FDA to promulgate a MOU to “address” the “distribution” of “inordinate amounts” of compounded drugs interstate and that it “shall issue regulations” to do so.

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Camargo

JANUARY 27, 2021

Where is the regulation found? 21 Code of Federal Regulations (CFR) §316 ; Orphan Drug Act. Section 529 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)/ 21 United States Code (USC) §360ff. Sources: CFR – Code of Federal Regulations Title 21. Orphan Drug Designation. Rare Pediatric Disease Designation.

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FDA Law Blog

APRIL 19, 2021

FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

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pharmaphorum

JULY 27, 2021

Illinois-headquartered Apar – which makes inhalers, syringe components, eye drop bottles and other delivery systems for pharmaceuticals, cosmetics and other sectors – is paying €8.70 per share in the initial deal, which will give it a 64.6% stake in the company. The deal values Voluntis at around $79 million (around $95 million).

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FDA Law Blog

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., use in education, construction, art, and jewelry). products intended for medical purposes).

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XTalks

NOVEMBER 14, 2022

In the US, it’s against the law to use the carcinogenic color additive Red 3 in cosmetics, such as lipsticks or blush or topicals. As a result, in 1990, the agency eliminated certain “provisionally listed” uses of the chemical — meaning cosmetics and externally applied drugs. But those steps were never taken.

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FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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FDA Law Blog

DECEMBER 21, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won & Lisa M. medication reconciliations and test reconciliations); Reminders for preventive care or clinician’s orders; and.

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XTalks

APRIL 14, 2023

These regulations are long overdue, by almost a decade. If enacted, these updated regulations would reduce emissions in fenceline communities,” said Darya Minovi, a senior researcher scientist at the Union of Concerned Scientists, in a CNN report.

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pharmaphorum

OCTOBER 27, 2022

Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders?

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FDA Law Blog

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? While the political process plays out many FDA employees will be furloughed and told to not report for duty.

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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