Roots Analysis

AUGUST 7, 2023

Moreover, cell based biomanufacturing imposes inherent limitations on the effective production of biologics. Given the growing demand for biologic products, cell free expression has become a key focus area for stakeholders in the biopharmaceutical industry. Interestingly, most of these kits are used for cell-free protein expression.

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Marketing Protein In-Vitro Production 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

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.,

Genome 52

Genome Genomics Production Marketing 52

The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The FDA is working with the company to initiate a voluntary recall External Link Disclaimer of the affected products. Families rely on stores like Family Dollar for products such as food and medicine.

Contamination 52

Contamination Production Cosmetics Packaging 52

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. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

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Production Insulin Branding Generic Drugs 78

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.

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

World of DTC Marketing

JUNE 6, 2021

Still study trials show Wegovy is more effective than any other weight loss management drug currently on the market. Medicare currently doesn’t cover treatments for obesity because it categorizes medications for weight loss as cosmetic, like medications for hair loss. appeared first on World of DTC Marketing.com.

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Drugs Cosmetics Production FDA Approval 318

BioTech 365

AUGUST 7, 2020

LONDON–(BUSINESS WIRE)–#FermentationChemicalsMarket–Technavio has been monitoring the fermentation chemicals market and it is poised to grow by $ 26.38 bn during 2020-2024, progressing at a CAGR of 6% during the forecast period.

Cosmetics 52

Cosmetics Marketing Production 52

Delveinsight

SEPTEMBER 20, 2021

The condition is not life-threatening, however, is often wrongly presumed as purely a cosmetic problem leading to ignorance and delay in the treatment. The Onychomycosis treatment market offers several options, including oral antifungals, topical antifungals, and devices. Penlac (Valeant Pharmaceuticals, Inc.),

Marketing 74

Marketing Cosmetics Drug Delivery Clinical Development 74

Roots Analysis

JANUARY 29, 2024

It is interesting to note that medical aesthetics companies are continuously enhancing their product portfolio to provide solutions based on the needs of the end user. The medical aesthetics companies are offering advanced products and devices to perform these procedures with better results and minimal downtime.

Filler 40

Filler Cosmetics Botox Marketing 40

FDA Law Blog

JANUARY 7, 2024

As a result, failure to conduct a PMR would be a violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and/or implementing regulations, subject to enforcement action. Emphasis added.)

Marketing 59

Marketing Drugs Regulation Cosmetics 59

Fossil Remedies

OCTOBER 16, 2022

In a pharma business, you have a distribution network like a pharma manufacturing company, pharma marketing company, C&F agents, wholesalers/distributors/stockiest, retailers, and pharmacies. Every pharma company needs a drug license number to begin distribution, marketing, and manufacturing activities. Manufacturing Drug License.

Licensing 52

Licensing Licensing Pharma Companies Cosmetics 52

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.

Filler 40

Filler Cosmetics Production Dermatology 40

XTalks

NOVEMBER 24, 2022

Earlier this week, the US Food and Drug Administration (FDA) sent out warning letters to five companies illegally selling CBD-infused food and beverage products. 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.

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Production Branding Cosmetics Marketing 52

Pharmaceutical Technology

MARCH 30, 2023

The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than in FY 2023, a 10% increase. This is made up of $2.1bn in direct funding and $2.4bn in user fees. Postmarket Safety Collaborative: +$10.1m for a total of $36.8m

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Contract Manufacturing Manufacturing Pharma Companies Cosmetics 147

FDA Law Blog

APRIL 21, 2024

For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to receive such permission on the next business day.

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Production FDA Approval Marketing Cosmetics 59

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. Together, we aim to help our clients to bring therapies faster to market with digital platforms and our expertise.”

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Pharmaceutical Technology

MARCH 1, 2023

It discovers, develops and manufactures prescription drugs to treat cancer, multiple sclerosis and infertility; and develops liquid crystal mixtures, organic light-emitting diode (OLED) materials, cosmetic active ingredients, pigments for coatings, and high-tech materials.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

It discovers, develops and manufactures prescription drugs to treat cancer, multiple sclerosis and infertility; and develops liquid crystal mixtures, organic light-emitting diode (OLED) materials, cosmetic active ingredients, pigments for coatings, and high-tech materials.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

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.

Pharma Production 81

Pharma Production Pharma Companies Production Contract Manufacturing 81

Cloudbyz

MAY 26, 2023

The cosmetics and personal care industry is one where customer trust is paramount, given that the products are applied directly to the skin, hair, and body. These solutions are designed to monitor, detect, evaluate, and prevent any adverse effects associated with the use of a product after it has been released on the market.

Cosmetics 52

Cosmetics Compliance Branding Production 52

The Pharma Data

NOVEMBER 8, 2020

We are very pleased to announce the achievement of two key milestones in our strategy to pursue specific clinical indications that will enable us to market and sell Renuvion ® for target procedures in the cosmetic surgery market,” said Charlie Goodwin, President and Chief Executive Officer.

Cosmetics 52

Cosmetics Marketing Containment Manufacturing 52

FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

XTalks

JANUARY 19, 2021

This includes some flavored e-cigarettes imported to the US that do not meet Federal Food, Drug and Cosmetic Act (FD&C Act) requirements, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The warning letters notified the companies to remove their products from the market.

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Production Cosmetics Marketing Branding 98

Advarra

JULY 26, 2022

Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. In order to understand the current status on cannabis and CBD research studies, it’s important to understand where each product stands.

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Regulation Research Production Cosmetics 97

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. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development 161

Development Production Immune Response Licensing 161

Camargo

SEPTEMBER 8, 2021

On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. For some time, the FDA has asserted its authority to decide on the classification of a product which met the definition of both a drug and a device.

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Development Regulation Production Drugs 186

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.

Branding 105

Branding Cosmetics Production Marketing 105

pharmaphorum

FEBRUARY 11, 2022

Privately-held Mayoly Spindler is a specialist in gastroenterology and dermato-cosmetic products that has set itself the target of becoming a top 10 European OTC medicines company in the next 10 years. billion takeover of Clementia Pharma in 2019. billion of its revenues last year.

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Sales Pharma Companies Branding Cosmetics 103

FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 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).

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

pharmaphorum

OCTOBER 27, 2022

The Guidance applies to both product-related and therapeutic-area-related activities. Websites – Companies can use appropriate search engine optimisation (SEO) and marketing tools to ensure that their websites are displayed high on the list of results for relevant key word searches. About the authors.

Life Science 98

Life Science Compliance Regulation Cosmetics 98

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. In the pre-market area, Ms. In the post-market area, Ms. In addition, Ms. Before joining HP&M, Ms. Gaulkin practiced FDA law at an AmLaw 100 firm.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

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. This concept of operationalizing (operationalization?)

Drugs 52

Drugs Marketing Containment Production 52

Roots Analysis

FEBRUARY 20, 2022

In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Role of nanoparticles has been well established across various markets, such as healthcare, paint, consumer products ( including sunscreens, cosmetics ), aerospace and glass industries.

Contract Manufacturing 52

Contract Manufacturing Bioavailability Manufacturing Drug Delivery Systems 52

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. Some of their product ranges are: 400+ Antibiotics and general products. 150+ Cardiac & Diabetes Product.

Pharma Companies 52

Pharma Companies Production Marketing Branding 52

FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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Compliance Drugs Regulation FDA Approval 52

The Pharma Data

MAY 27, 2022

“We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the U.S. These Neocate amino acid-based formula products — some of which are already manufactured for the U.S. Califf, M.D. “We as quickly as possible.

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Production Manufacturing Pharmacy Cosmetics 52