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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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

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. Other major brands like PepsiCo and Carl’s Jr. have dipped their toes into the hemp product market with various CBD-infused food and beverage products.

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Fossil Remedies

JUNE 18, 2020

PCD Pharma Companies are those companies, which provides products to its franchise partners and also distributorship rights and monopoly of marketing for the given geographic area or location. It has a significant presence in brands across all therapeutic segment like from cough & cold to life threatening serious diseases.

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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. In Europe, brands like Nestlé use radish, lemon and red cabbage extracts as a food coloring in their chocolates. 40 and yellow food dyes no.

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XTalks

JULY 1, 2024

The financial market’s volatility and shifting consumer spending habits have contributed to this trend. Despite these challenges, three notable companies have debuted on the stock market. This focus has allowed it to expand rapidly across Asia and into international markets. Cava Group, Inc.

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FDA Law Blog

DECEMBER 21, 2023

Those who attended their annual Enforcement, Litigation, and Compliance Conference holiday reception earlier this month got a sneak peek at this new branding effort with the unveiling of the association’s new logo ( here ). The new logo — and a host of other new association branding—will be rolling out throughout 2024.

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XTalks

FEBRUARY 8, 2021

Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed. MYTH: Interchangeable biological products have achieved a higher level of biosimilarity.

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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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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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Roots Analysis

JANUARY 17, 2024

Resilience of Eli Lilly in the Face of Challenges The latter half of the previous decade witnessed Eli Lilly grappling with stagnant market value and declining revenue, hovering around the USD 100 billion mark. As the drug gains momentum, the demarcation between medical and cosmetic applications becomes increasingly nuanced.

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XTalks

OCTOBER 10, 2024

It argues that Lilly has a vested interest in dominating the market, accusing the company of acting out of self-interest to maintain a market monopoly. The FDA’s decision effectively shuts off a pathway that had allowed these pharmacies to dispense the drugs when the branded versions were in short supply.

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XTalks

MARCH 13, 2024

This led people to seek it off-label for cosmetic weight loss, a phenomenon many say is partly to blame for the current shortages of both Novo and Lilly’s GLP-1 drugs. Novo’s weight loss version of Ozempic is branded Wegovy (semaglutide). This isn’t the first time the GLP-1 drugs made it to the Oscars.

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Pharma Marketing Network

APRIL 4, 2022

Many of the medical device and pharma companies are aware of this, and the professional side of AAD.org has benefitted from this relationship, but I noticed during the show that many of the cosmetic and hygiene brands were completely unaware that they could be advertising on the patient side of the website.

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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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The Pharma Data

FEBRUARY 5, 2021

CoolSculpting ® has been an industry-leader, creating the market for non-invasive fat reduction over 10 years ago. ” said Dr. Sabrina Fabi , Board Certified Dermatologist and Associate Research Director at Cosmetic Laser Surgery in San Diego. “The number one aesthetic concern for consumers is excess body fat 1.

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The Pharma Data

MAY 18, 2021

GSK Consumer Healthcare (GSKCH), the world-leading consumer healthcare business, announced today that it is partnering with two global packaging suppliers to launch fully recyclable toothpaste tubes across its specialist and science-based oral health brands, including Sensodyne, parodontax and Aquafresh. About Albéa. Source link.

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The Pharma Data

MAY 27, 2022

market and are made at facilities in Europe — amounts to more than 5 million full-size, 8-ounce bottles. On Tuesday, the FDA announced that it informed Kendal Nutricare that the agency is exercising enforcement discretion for the importation of certain infant formula under the Kendamil brand. as quickly as possible.

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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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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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XTalks

NOVEMBER 7, 2023

Some may even extend their expertise to consumer goods sectors, including cosmetic brands. The US Bureau of Labor Statistics (BLS) projects that the job market for medical scientists, which includes medical science liaisons, will grow by 17 percent between 2021 and 2031, a rate that surpasses the average across all professions.

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Intouch Solutions

JUNE 30, 2022

47% of those had made in-game purchases, and 37% had purchased virtual cosmetic items. But brands are increasingly going to have to address this unfamiliarity, and normalize therapeutics that aren’t just made out of cellulose and proteins. And 79% of their 3,000 survey respondents said that they had already – not someday!

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FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. More than a few have taken far longer—literally decades.

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FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. That’s right!

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FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. That’s right!

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XTalks

JULY 6, 2022

Plant-based e-commerce platform PlantX recently announced a partnership with ice cream brand Dream Pops at its multi-brand pop-up retail initiative in Venice Beach, California. It stocks thousands of vegan products on its website, plus a meal delivery service called XMeals , which recently expanded to the US market.

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XTalks

JUNE 17, 2024

Hugel, a Korean medical aesthetics company, recently announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its botulinum toxin, Letybo (letibotulinumtoxinA-wlbg), for the treatment of glabellar lines. We are thrilled with the FDA’s approval of Letybo. “We What Is the Price of Letybo?

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pharmaphorum

FEBRUARY 11, 2022

Ipsen’s consumer health range includes brands like diarrhoea remedy Smecta, Forlax for constipation and Ginkgo biloba supplement Tanakan, which recorded revenues of €226 million in 2021, up 8%. Ipsen’s specialty pharma business grew almost 13% to €2.6 billion last year. billion takeover of Clementia Pharma in 2019.

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pharmaphorum

DECEMBER 15, 2022

Within the life sciences space, traditional ways of leveraging social media include marketing and spreading awareness of a disease or treatment. Healthcare Provider (HCP) marketing. Still, many pharma and medical marketers have been reluctant to engage with HCPs on social media. Direct-to-Consumer (DTC) marketing.

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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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pharmaphorum

OCTOBER 27, 2022

Companies are responsible for all content disseminated via a digital channel when the content is initiated, branded, and/or sponsored by the company or a third party acting on its behalf. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates. What are the key points from the Guidance?

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FDA Law Blog

DECEMBER 8, 2021

Moore — Nothing says “happy holidays” quite like the issuance of Federal Trade Commission (FTC) orders – essentially, subpoenas – to large retailers , wholesalers and suppliers of food, cosmetics, personal care and OTC products, among other things, during the supply chain’s busiest time of the year.

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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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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. These distinctions are important as they determine the regulatory burden required to market a product in Canada. Links to decisions: Le-Vel Brands, LLC v.

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XTalks

NOVEMBER 1, 2024

The neurology drug market continues to be dynamic with novel treatments that cater to a broad range of neurological and psychiatric conditions. In 2024, several blockbuster neurology medications are set to lead the market, capturing the attention of healthcare professionals, investors and patients alike. as of January 2024.

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FDA Law Blog

JANUARY 1, 2025

The safe harbor applies only when the labeling, promotion, or commercial marketing does not reference the condition(s) of use claimed in the patent. This bill would go a long way to alleviating the concerns of the generic industry (AAM has applauded it), but it will clearly have objections from the brand side.

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FDA Law Blog

JANUARY 8, 2025

Koblitz Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing. Nine patents are listed in the Orange Book with ProAir HFA.

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