AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 16, 2023

The Drug Controller General of India (DCGI) has issued a show cause notice to online pharmacies including Tata 1mg for allegedly stocking and selling drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules, once again bringing back the long pending issue of lack of regulations on e-pharmacies under the […]

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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

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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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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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

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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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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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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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

JULY 8, 2021

Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). At various points and in various ways, FDA has sought – mostly unsuccessfully – to regulate LDTs (see here ).

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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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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

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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Pharma in Brief

JANUARY 7, 2024

Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen. As we reported , the export regulations first issued as an interim order in November 2020, in response to the FDA publishing the US Importation Rule in October 2020. 01.014.13).

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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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ProRelix Research

JUNE 26, 2023

As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, […] The post US FDA Medical Device Applications appeared first on ProRelix Research.

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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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XTalks

MARCH 21, 2024

An additional $8 million is allocated for the Modernization of Cosmetics Regulation Act (MoCRA), which aims to enhance cosmetic product safety. Modernization and Mission Support The FDA food budget proposes $114.8 million to cover inflationary pay costs and cost-of-living adjustments to maintain its qualified, specialized staff.

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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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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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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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The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Today, the U.S. We will continue to work to protect consumers.”. 1, 2021, through the present.

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Pharmaceutical Technology

MARCH 30, 2023

The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than in FY 2023, a 10% increase. Restarting Cancer Moonshot: +$48m, for a total of $50m for President Biden’s pet project. Source: FDA © GlobalData

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FDA Law Blog

JULY 13, 2021

Prior posts on the BE Standard and its implementing regulations can be found here , here , and here. The BE standard and its implementing regulations require food containing any amount of a bioengineered substance that is not inadvertent or unintentional to bear a disclosure.

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FDA Law Blog

JANUARY 5, 2022

Sara also has been heavily involved in FDA-related litigation and interpretation of the Federal Food, Drug, and Cosmetic Act. Related Stories Congratulations to HP&M’s first Principal Medical Device Regulation Expert, Adrienne Lenz. Sara joined the firm from a well-recognized intellectual property firm in 2017.

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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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FDA Law Blog

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.

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Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. The Guidance was last updated in 2005.

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FDA Law Blog

NOVEMBER 15, 2022

At DOJ, Mr. Claud prosecuted and supervised complex criminal and civil trial litigation and investigations under the Food, Drug, and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act, and Federal data privacy laws.

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FDA Law Blog

MARCH 24, 2024

Field preemption applies when federal regulation occupies the regulated area so pervasively that it leaves no room for states to supplement it, even if the state law is consistent with the federal law. The court also noted that the practice of pharmacy is an area traditionally left to state regulation.

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The Pharma Data

MARCH 29, 2022

an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., Related Information. Bravo Packing, Inc.

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FDA Law Blog

JUNE 28, 2023

The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food. On October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims.

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FDA Law Blog

AUGUST 19, 2021

A food would be misbranded unless its principal display panel bears “summary nutrition information that reflects the overall nutritional value of the food or specified ingredients” as required in regulations that would be issued by FDA. As noted in the previous iterations, the 2021 FLMA focuses on nutrients.

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FDA Law Blog

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs. And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.

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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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