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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BioTech 365

NOVEMBER 30, 2020

Lygos and High Beauty Sign Agreement to Co-Develop and Commercialize Cosmetic Products Containing Rare Cannabinoids Lygos and High Beauty Sign Agreement to Co-Develop and Commercialize Cosmetic Products Containing Rare Cannabinoids Co-branded High & Bye Refining Oil and Clearing Gel to … Continue reading →

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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.

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Pharma Mirror

DECEMBER 1, 2021

CPhI awards the first ever CPhI Verified certificate to Medinfar – an international pharmaceutical manufacturer of Rx, cosmetics, food supplements and veterinary products. The service forms part of the platinum membership on CPhI Online and is designed to further supply.

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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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pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. If so, developers must develop and execute on a regulatory strategy.

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Pharmaceutical Technology

MAY 16, 2023

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

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The Pharma Data

JUNE 18, 2021

June 8, 2021 /PRNewswire/ — Allergan Aesthetics, an AbbVie company (NYSE: ABBV ), is changing the way BOTOX ® Cosmetic, the #1 selling neurotoxin treatment 1 , is connecting with consumers. “BOTOX ® Cosmetic is honoring and celebrating the dynamic people who use our products. IRVINE, Calif.

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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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Scienmag

SEPTEMBER 16, 2020

Goddard III A research team from Caltech and the UCLA Samueli School of Engineering has demonstrated a promising way to efficiently convert carbon dioxide into ethylene — an important chemical used to produce plastics, solvents, cosmetics and other important products globally.

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XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?

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pharmaphorum

OCTOBER 4, 2022

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). The post Considerations for Mobile Health Technology Developers: Part 2 appeared first on. The final guidance follows the draft CDS software guidance issued on the same date in 2019.

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XTalks

DECEMBER 10, 2020

Funded by EIT Food , the Digital Marketplace for Side Streams will help food companies upcycle waste to produce by-products by matching them with businesses that have an overabundance of food. The goal of the marketplace is to inspire more companies to consider ways they can reduce waste from food production.

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FDA Law Blog

DECEMBER 12, 2022

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). Please check out FDA’s presentation on this very topic – Is My Product a Medical Device?

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Pharmaceutical Technology

JUNE 10, 2023

Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Buy the report here.

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Pharmaceutical Technology

JUNE 10, 2023

Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Buy the report here.

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Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Neuroendocrine Tumors. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Merck overview Merck, a subsidiary of E.

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Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Head And Neck Cancer Squamous Cell Carcinoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Gene Editing DNA Cosmetics Life Science 100

Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

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Fossil Remedies

APRIL 7, 2020

Having headquarters in Ahmadabad, Gujarat, ‘ Fossil Remedies ’ is the top most Pharma franchises company in India with long years of experience.They manufacture and market more than 2800+ Pharma products and indulge in 8 Special divisions. Some of their product ranges are: 400+ Antibiotics and general products. Dental Products.

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Camargo

AUGUST 22, 2021

To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. This validation check determines if the submission is uploaded into the FDA’s system, or if it is technically rejected.

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FDA Law Blog

SEPTEMBER 30, 2021

See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2). The Plaintiffs’ complaint alleges both substantive and procedural violations in FDA’s development of the MOU. FDA finally settled on a “final” MOU a year ago, and a coalition of compounding pharmacies immediately filed suit.

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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). “It Today, the U.S.

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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. However, FDA’s interpretation creates that exact risk for a dietary supplement manufacturer who invests in development of a dietary supplement.

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XTalks

JULY 26, 2023

We are primed and ready for our next major leap — the global scale production of Brevel’s protein that will be integrated into healthier, tastier and environmentally-friendly food products in every household.” The first food products containing Brevel’s protein are scheduled to hit the market by 2024.

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XTalks

JULY 6, 2022

Plant-based diets have skyrocketed over the last few years, but anyone who follows this lifestyle will know that it can be difficult to identify products that are truly ethical and free of animal products. It may even expand to other areas, such as clothing, water and cosmetics. That’s where PlantX comes in.

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Branding Cosmetics Production Marketing 105

Clinical Trial Podcast

JULY 31, 2022

He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health. Previously, Darshan was on the editorial board of cosmetics and personal products for FDAnews where guided the publication with his clinical trial and pharmaceutical expertise.

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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

JANUARY 12, 2025

FDAs application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s. Moreover, it was also interesting to see how FDA discussed the concept of unmet medical need in the limited fashion that it did in this new guidance.

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BioTech 365

AUGUST 10, 2020

Nasdaq: SLP), a premier developer of drug discovery and development software for modeling and simulation software products and services for the pharmaceutical, biotechnology, agrochemical, cosmetics and food industries, today announced the closing of its previously … Continue reading → LANCASTER, Calif.–(BUSINESS

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BioTech 365

AUGUST 5, 2020

Nasdaq: SLP), a premier developer of drug discovery and development software for modeling and simulation software products and services for the pharmaceutical, biotechnology, agrochemical, cosmetics and food industries, today announced the entry into an underwriting … Continue reading → LANCASTER, Calif.–(BUSINESS

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pharmaphorum

DECEMBER 9, 2021

After making her way from early-stage drug development research to her current role, Heather got straight to work on creating sustainable collaborations that made life better for people and their families. “I I am fascinated by the breadth of my role, which encompasses self-care products, skin health, sustainability and much more.

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Allergies Life Science Development Scientist 105

Cloudbyz

APRIL 12, 2022

As part of this partnership, ClinChoice will offer Cloudbyz’s digital clinical research solutions to their pharmaceutical, biotechnology, medical device, and consumer product clients. Product Marketing Manager 1-630-425-5475 marketing@cloudbyz.com. Media Contact : Grace Anderson Sr.

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

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pharmaphorum

OCTOBER 27, 2022

The Guidance applies to both product-related and therapeutic-area-related activities. In the EU and UK, where direct-to-consumer promotion of POMs is prohibited, companies may not sponsor blogs that promote, or could reasonably be expected to promote, such products. Digital Channels include, but are not limited to, social media ”.

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XTalks

JUNE 17, 2022

Treatments for AA have been limited and largely cosmetic, such as the use of wigs and false eyelashes, or corticosteroid injections in the scalp. It blocks the activity of JAK1 and JAK2 to interfere with the JAK-STAT signaling pathway to dampen the production of inflammatory cytokines through the modulation of gene expression.

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The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction. Opioid misuse and abuse remain a serious public health crisis facing the country. Source link: [link].

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