Rethinking Clinical Trials

JANUARY 31, 2024

Winckler is the chief executive officer of the Reagan-Udall Foundation for the FDA, a nonprofit organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.” Join the online meeting.

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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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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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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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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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BioTech 365

JULY 28, 2021

DIC, Debut Biotech Team Up to Develop and Bio-Manufacture Natural Pigments for More Sustainable Food Colorants and Cosmetics DIC, Debut Biotech Team Up to Develop and Bio-Manufacture Natural Pigments for More Sustainable Food Colorants and Cosmetics TOKYO–(BUSINESS WIRE)–DIC Corporation (TOKYO:4631) … Continue reading →

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pharmaphorum

SEPTEMBER 29, 2022

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. Food and Drug Administration (FDA) regulation as a medical device.

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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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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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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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Pharmaceutical Technology

APRIL 4, 2023

On April 4, Scorpion Therapeutics announced a collaboration and license agreement with the French dermo-cosmetic and pharmaceutical group Pierre Fabre to codevelop two next-generation epidermal growth factor receptor (EGFR) inhibitors. of NSCLC patients with exon 19 and 21 mutations develop resistance mutations at C797S. Up to 12.5%

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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. FDA argues that technological advances in LDTs necessitate FDA’s regulatory oversight pursuant to the Food, Drug, and Cosmetic Act (FDCA). By Jeffrey K.

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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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Gene Editing DNA Cosmetics Life Science 100

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

pharmaphorum

JULY 27, 2021

Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. per share in the initial deal, which will give it a 64.6% stake in the company.

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Scienmag

DECEMBER 10, 2020

Environmental risk assessment through the development of an artificial organ-based toxicity assessment.

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Cosmetics Development Engineer 52

XTalks

DECEMBER 10, 2020

Cosmetics and pharmaceutical companies can also participate in the circular economy by reducing waste and allowing other firms to create by-products. The company recently developed a plant-based, nutrition-packed protein called CanolaPROTM that was made from a by-product of crushed and oil-extracted rapeseed.

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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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XTalks

JULY 5, 2022

It’s a treatment that fulfills a big unmet need in cosmetic procedures,” citing noteworthy results seen firsthand in patients. As with all cosmetic procedures, there are some risks associated with the use of the Renuvion Dermal handpiece. Tabasum Mir states that “Renuvion for facial procedures is ground-breaking.

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FDA Law Blog

MAY 17, 2021

You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID?19 At the time, we wrote favorably about this move. Put bluntly, the review of COVID?19

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Development Cosmetics Regulation In-Vitro 52

pharmaphorum

MAY 27, 2022

First launched in 2006, Roblox is an online space where users can play games – more than 20 million of them at a recent count – created by developers and individuals. EndeavorRx will connect to Roblox, and playing it will unlock cosmetics that draw on the design of the game.

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FDA Law Blog

JANUARY 30, 2025

This condition was included in the final rule for the original regulations, 21 CFR 314 Subpart H (see the December 11, 1992 Federal Register, 57 FR 58958 ) as well as when the pathway was codified in the Federal Food, Drug, and Cosmetic Act by FDAMA (21 USC 356(c)) in 1997. However, the meaning of due diligence has long been a question.

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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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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

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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Camargo

JANUARY 27, 2021

The US FDA offers sponsors a variety of special designation programs to incentivize them to develop and deliver therapies to treat unmet patient needs, such as Fast Track Designation (FTD), Breakthrough Therapy Designation , and Qualified Infectious Disease Product Designation. Office of Orphan Products Development.

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pharmaphorum

JULY 16, 2021

The deal gives Ipsen worldwide rights to the mid-stage drug – called mesdopetam – and puts the company on the hook for another $335 million in development, regulatory and sales milestones. Servier has since stepped in as the partner for that project, which remains in preclinical development.

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Delveinsight

JANUARY 6, 2021

As a result of the high healthcare cost, people from developed countries move from their home country to another to receive treatment. In the past, most people from developing countries used to travel to developed countries for healthcare services due to the availability of advanced technology and healthcare specialists.

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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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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. Individuals can develop alopecia at any age, but most develop it during childhood or teenage years.

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FDA Approval Gene Expression Cosmetics Trials 97

FDA Law Blog

MAY 17, 2021

Shapiro — You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID?19 At the time, we wrote favorably about this move. Put bluntly, the review of COVID?19

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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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The Pharma Data

NOVEMBER 10, 2020

HOUSTON–( BUSINESS WIRE )– Vapogenix, a clinical-stage company developing a new class of topical non-opioid, lidocaine-free analgesics, today announced it has been awarded a $1.5M We are developing a much needed new product with a novel dual mechanism, good efficacy and excellent safety profile. 11, 2020 10:30 UTC.

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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. According to GlobalData, there are 60+ companies, spanning technology vendors, established pharmaceutical companies, and up-and-coming start-ups engaged in the development and application of lipase compositions.

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