FDA Law Blog

JANUARY 29, 2025

Aside from his many high profile claims about vaccines, what he perceives as corruption at FDA, and his promise to go wild on health, Kennedys specific policy preferences about how FDA should administer its day-to-day oversight of drugs, medical devices, food, dietary supplements, cosmetics, or tobacco have not been publicly detailed.

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Scienmag

FEBRUARY 24, 2021

New method could advance next-generation applications in medicine, cosmetics, and petroleum recovery Credit: Paul Ashby and Tom Russell/Berkeley Lab and Science Advances Liquid structures – liquid droplets that maintain a specific shape – are useful for a variety of applications, from food processing to cosmetics, medicine, and even petroleum (..)

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Cosmetics Medicine Research 41

pharmaphorum

FEBRUARY 11, 2022

If consummated, the deal would bring in around €350 million for Ipsen , leaving the company as a specialty pharma pure-play in cancer, rare diseases and neuroscience and ending its strategy of adopting a combined prescription and over-the-counter (OTC) medicines business model. billion takeover of Clementia Pharma in 2019.

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pharmaphorum

MAY 27, 2022

The platform has a built-in currency called ‘Robux’ that can be used to buy some games, as well as “cosmetics” – digital items for character customisation like hats, hairstyles or clothing. EndeavorRx will connect to Roblox, and playing it will unlock cosmetics that draw on the design of the game.

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pharmaphorum

OCTOBER 27, 2022

However, there is a general prohibition in the legislation of using celebrities to promote medicines. Jackie Mulryne, Partner, is a member of the Life Sciences practice group, and provides regulatory, policy, and compliance advice to clients in the pharmaceutical, medical technology, cosmetics, and foods sectors.

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Camargo

SEPTEMBER 8, 2021

In August, the generic trade organization the Association for Accessible Medicine filed an amicus brief urging the court to reject a report filed in the case supporting continuation of the suit. Hikma Pharmaceuticals USA Inc. The case was filed in December of 2020 and is ongoing.

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Scienmag

FEBRUARY 9, 2021

Credit: MostPhotos/Tatiana Mihailova Our consumer products, such as food, cosmetics and clothes, might be filled with nanomaterials – unbeknownst to us. The use of nanomaterials remains unregulated and they do not show up in lists of ingredients.

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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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Cosmetics Compliance Generic Drugs Regulation 59

Fossil Remedies

OCTOBER 16, 2022

A Wholesale Drug License is required when you want to sell medicines in bulk quantities. When you want to sell medicines at a retail store, this license is required. This is not needed for a pharma manufacturing company as it will not be selling medicines in small quantities to retailers. Retail Drug License.

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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. In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product.

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Production Cosmetics Regulation Branding 52

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available.

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Pharmaceutical Technology

APRIL 18, 2023

They are used as biocatalysts in pharmaceutical production, such as polymer synthesis, cosmetics, flavouring agents, and similar. GlobalData’s analysis also uncovers the companies at the forefront of each innovation area and assesses the potential reach and impact of their patenting activity across different applications and geographies.

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Advarra

JULY 26, 2022

with 37 states approving medicinal use and 18 approving recreationally. 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.

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The Pharma Data

FEBRUARY 19, 2022

Families rely on stores like Family Dollar for products such as food and medicine. The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded. The FDA is working with the company to initiate a voluntary recall External Link Disclaimer of the affected products.

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Scienmag

MARCH 30, 2021

For some patients, these issues include chronic radiation-induced skin injury – which can lead to potentially severe cosmetic and functional problems. March 30, 2021 – As cancer survival rates improve, more people are living with the aftereffects of cancer treatment.

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Cosmetics Medicine 40

Pharmacy Checkers

MARCH 6, 2020

The window for public comments on the FDA’s notice on proposed rulemaking about drug importation under Section 804 of the Food, Drug, and Cosmetic Act is closing on Monday March 9th – and I’m not done writing! So, this post will be short and sweet but highly relevant. Gotta get to it. Wash your hands.

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Drugs Cosmetics Pharmacy Medicine 54

XTalks

JANUARY 12, 2021

The US Food and Drug Administration (FDA) has sent a warning letter to Coco’s Holistic Specialties & Apothecary , an online holistic and Eastern medicine company, for falsely advertising its products’ ability to prevent, treat, cure and even diagnose people with COVID-19.

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FDA Law Blog

SEPTEMBER 30, 2021

See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2).

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XTalks

SEPTEMBER 4, 2020

Nowadays, the word’s meaning is commonly extended to refer to non-food products—such as clothing, cosmetics, and medicine—that are made without animal-derived substances. The word vegan was initially defined as a diet free of animal-based foods (such as meat, dairy products, eggs and honey.)

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Production Cosmetics Licensing Licensing 69

Pharmacy Checkers

JUNE 26, 2020

Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The new cooperation on Covid-19 is carried out under the auspices of International Coalition of Medicines Regulatory Authorities (ICMRA). We already rely on the EU to assess U.S. drug safety, and current events have only brought that into greater focus.

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Drugs Regulation Manufacturing Medicine 55

The Pharma Data

DECEMBER 4, 2021

is a topical prescription medicine used to treat acne vulgaris. Continuing to advance and launch much-needed generic drugs is critical to ensuring access to quality medicines to everyone who needs them.” NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century.

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FDA Law Blog

JULY 7, 2021

Senior Circuit Judge Sentelle, who drafted the opinion, found determinative the statutory restriction prohibiting FDA from interfering in the practice of medicine: When Congress has spoken in a statute, we assume that it says what it means and that the statute means what it says.

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XTalks

FEBRUARY 16, 2023

Quviviq is an FDA-approved prescription medicine that helps treat insomnia in adults, with a low risk of dependence and side effects. Other Jennifer Aniston Commercials Jennifer Aniston has been a part of many high-profile ad campaigns in her career, from cosmetics and fashion lines to health and wellness initiatives.

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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., Source link: [link].

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XTalks

JANUARY 5, 2024

Eli Lilly launched LillyDirect this week, an online service that provides access to the company’s medicines, including its newly approved weight loss drug Zepbound (tirzepatide). Along with the launch of LillyDirect this week, Lilly also issued an open letter recommending that Zepbound and Mounjaro not be used for “cosmetic weight loss.”

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Drugs Pharmacy Cosmetics Medicine 59

Cloudbyz

OCTOBER 19, 2023

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident.

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Pharmacy Checkers

DECEMBER 18, 2020

In late September, Secretary Azar, in a final rule , certified that importing drugs from Canada, subject to Section 804 of the Food, Drug and Cosmetic Act (Section 804), 21 U.S.C. In its lawsuit to stop wholesale drug importation programs that could help lower U.S.

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Pharmacy Drugs Cosmetics Licensing 85

The Pharma Data

DECEMBER 30, 2020

deputy director of the FDA’s Center for Veterinary Medicine (CVM) Division of Compliance: “Although this pet food recall is still unfolding, we are sharing the facts we have so far because the levels of aflatoxin found in the recalled pet food are potentially fatal. SILVER SPRING, Md. , SOURCE U.S. Food and Drug Administration.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”. Today, the U.S.

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Roots Analysis

JANUARY 3, 2024

Medical aesthetics is a growing area of modern medicine that focuses on improving the cosmetic appearance of an individual through various medical treatments. However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002. What is Medical Aesthetics?

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The Pharma Data

NOVEMBER 23, 2021

Anti-rejection medicines taken after surgery help help a rejection occasion, but they also inhibit part of the vulnerable system. The agency also is responsible for the safety and security of our nation’s food force, cosmetics, salutary supplements, products that give off electronic radiation, and for regulating tobacco products.

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XTalks

MARCH 25, 2024

“We’re seeing double the amount of weight loss you can achieve with this class of medications compared to what we’ve had in our toolbox for the last several decades, in combination of course with a healthy lifestyle,” said Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai, in the TV special.

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The Pharma Data

FEBRUARY 5, 2021

” said Dr. Sabrina Fabi , Board Certified Dermatologist and Associate Research Director at Cosmetic Laser Surgery in San Diego. American Society for Dermatologic Surgery (ASDS) consumer survey on cosmetic dermatologic procedures 2018 available at [link]. For more information and to find a provider near you, visit [link].

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The Pharma Data

NOVEMBER 29, 2021

deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research. “By The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Source link: [link].

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Roots Analysis

JANUARY 29, 2024

Medical Aesthetics is an area of modern medicine that specializes in improving the outer appearance of an individual without surgery. Body Contouring: Body contouring is a cosmetic procedure that aims to redefine, recreate and reshape the body. The procedure requires topical anesthesia and usually lasts for one to three years.

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FDA Law Blog

OCTOBER 14, 2021

Again, this situation raises the question of where FDA’s role ends and the surgeons’ role begins with regard to use of RAS devices in the field of medicine. Thus, this part of the Act becomes that much more important to healthcare providers innovating in the field of medicine. 21 U.S.C. § Anything more is unwarranted mission creep.

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The Pharma Data

MAY 16, 2021

Perhaps more than ever before in human history, we are facing a daily onslaught of toxins that many people are largely unaware of.

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