FDA Law Blog

MAY 6, 2024

The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C). In addition, manufacturers need to submit plans for monitoring, identifying, and addressing post market cybersecurity vulnerabilities. are cybersecure.

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FDA Law Blog

JULY 7, 2022

Sponsors have been unable to overcome the challenges of switching some widely used prescription drugs to OTC for a very long time and a path to market may be clearing for at least some of these and others. Drugs currently on the market OTC would not be approved with ACNU.

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XTalks

NOVEMBER 24, 2022

According to the warning letters, these products are considered adulterated under “section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. 331(ll) and 331(a).”. Other major brands like PepsiCo and Carl’s Jr.

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XTalks

SEPTEMBER 28, 2023

This meant manufacturers could skip the FDA’s exhaustive safety review process, ensuring their products reached the market faster. Parabens, which are also prevalent in cosmetics, can interfere with the regular operation of human hormonal systems, affecting both male and female reproductive health, development, fertility and birth results.

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FDA Law Blog

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients.

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Roots Analysis

JULY 28, 2024

While cosmetic procedures can effectively target specific aging concerns like deep wrinkles, sagging skin, and volume loss, they may not comprehensively improve the overall skin quality. Recent trends in the global skincare industry showcase a growing emphasis on personalization, multifunctionality, and the rise of the men’s skin care market.

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XTalks

APRIL 14, 2021

The US Food and Drug Administration (FDA) defines color additives as “any substance that imparts color to a food, drug, cosmetic, or the human body. After some research, they discovered that the treats did not look as vibrant as other children’s gummy snacks sold in the market.

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Pharma in Brief

JANUARY 7, 2024

Section 804 Importation Programs On October 1, 2020, the FDA published a rule entitled Importation of Prescription Drugs (the US Importation Rule ) to implement Section 804 of the Food, Drug, and Cosmetic Act. Biologics, controlled substances, and certain other drugs are not eligible for importation. 01.014.13).

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XTalks

APRIL 26, 2021

The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. Future Market Insights predicted in 2019, prior to the onset of the COVID-19 pandemic, that the upcycled food industry was worth more than $46 billion, with an estimated compound annual growth rate (CAGR) of five percent.

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FDA Law Blog

JUNE 28, 2023

ASCA was authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 2022 Device Submissions with ASCA Testing According to the ASCA 2022 Annual Report , the “FDA received five submissions that contain ASCA testing: four with basic safety and essential performance testing and one with biocompatibility testing.

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FDA Law Blog

APRIL 19, 2023

Module 5 should also include information about safe nonprescription marketing and use if the proposed drug contains an active ingredient not previously contained in certain OTC monographs or orders, and any postmarketing safety information.

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FDA Law Blog

APRIL 21, 2024

Taiho’s counsel quickly followed up with a letter to FDA and a supplemental submission to the PTO in February 2024 arguing otherwise: “[P]ermission for commercial marketing” was not effective under the September 30, 2022 FDA letter because the product would have been misbranded if marketed thereunder. sections 331(a) and 352.(a)(l),

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FDA Law Blog

OCTOBER 17, 2021

Perhaps one day those numbers will be as familiar as references to the various parts of the CFR containing the monographs (maybe). We here at HPM hope that FDA will continue to maintain the webpage Status of OTC Rulemakings which contains easily accessed historical information and links. For each OTC monograph title (e.g.,

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FDA Law Blog

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. DASCA became law, amending the CSA, on December 18, 2014.

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Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . There are 19,000 approved prescription drugs for marketing in the U.S. and other high-income countries.

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The Pharma Data

DECEMBER 4, 2021

The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes. 2.5%), in the United States.

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FDA Law Blog

JULY 26, 2022

Like all Guidance documents, it starts out with background, explaining that the Orange Book is FDA’s list of drug products approved under the Federal Food, Drug, and Cosmetic Act and contains patent and exclusivity information related to such products.

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The Pharma Data

DECEMBER 29, 2020

Federal Food, Drug and Cosmetic Act (“FD&C Act”), regarding the regulatory requirements applicable to its robotically assisted surgical device (“RASD”), the Enos Robotic Single Access System. market clearance,” said David McNally, President and Chief Executive Officer of Titan. “At Enos is a trademark of Titan Medical Inc.

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The Pharma Data

NOVEMBER 26, 2020

We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. The company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment.

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FDA Law Blog

NOVEMBER 1, 2023

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 ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

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FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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The Pharma Data

JANUARY 31, 2021

BIOLASE is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE’s principal products are revolutionary dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. About BIOLASE, Inc.

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FDA Law Blog

JUNE 12, 2023

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. By Riëtte van Laack — FDA regulates pet food similar to other animal foods.

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The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). For additional information, please visit www.crescitatherapeutics.com.

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FDA Law Blog

FEBRUARY 15, 2022

A meeting that is necessary to address an important safety issue that needs immediate action when the meeting requester learns about a safety issue related to an OTC monograph drug that is marketed or being developed. By Deborah L. An OMOR submission when a meeting requester has an interest in initiating an OMOR (i.e.,

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FDA Law Blog

NOVEMBER 14, 2022

Specifically, the guidance states that FDA considers overpackaging to be the enclosure of individual drug products that each bear full and complete labeling information required under the FDC Act to allow legal marketing individually.

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The Pharma Data

DECEMBER 28, 2020

Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. 31, 2019, the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. 5 th ed.

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FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. From there, the PTO notes that a PTE “determination is made based on the representations contained in the PTE application,” and that “35 U.S.C. §

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The Pharma Data

NOVEMBER 4, 2020

Key findings of the research showed that patients with alopecia areata suffer significantly increased burden of illness, including a negative impact on many aspects of daily life, extending considerably beyond the cosmetic concerns of hair loss. Unrealized gain (loss) on marketable equity securities.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 – Nearly 15% of talc-based cosmetic products analyzed in a recent study contained asbestos. Environmental Working Group (EWG) — an American advocacy nonprofit that commissioned the tests and did the analysis — said methods used by the cosmetics industry to screen talc supplies are inadequate. MONDAY, Nov.

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The Pharma Data

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). Today, the U.S. Solomon, D.V.M.,

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FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). Do you really have to identify both “Grants” to be correct? Lehman , No.

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FDA Law Blog

JANUARY 1, 2024

of Miami, Florida, a contract manufacturer of over-the-counter (OTC) drug products, including oral cough and cold drug products marketed for both adults and children, was also advised in a Warning Letter to retain an independent expert on good manufacturing practices. Patcos Cosmetics Pvt. Dextrum Laboratories Inc. Terragene S.A.,

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FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. 21 U.S.C. § 802(16)(B).

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Roots Analysis

SEPTEMBER 9, 2024

In addition, other industries, such as agriculture, cosmetics, food, environmental sciences, biomedical research and enzyme synthesis industry, are also benefiting from the protein expression process. To date, she has contributed to over five full length market research projects.

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FDA Law Blog

NOVEMBER 22, 2021

This new draft guidance document applies to “device software functions” that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C 17 Act). It does not apply to software-related documentation that may be needed to evaluate post market software device issues (e.g.,

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The Pharma Data

MARCH 15, 2022

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D.,

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