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.

Development 186

Development Regulation Production Drugs 186

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

Pharma in Brief

NOVEMBER 20, 2023

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

Production 52

Production Cosmetics Regulation Branding 52

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.

Production 98

Production Cosmetics Marketing Branding 98

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

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 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

FDA Law Blog

APRIL 13, 2025

This letter, dated March 21, 2025, cites Taihos false or misleading representations about the benefits of the drug, which is considered misbranding under the Federal Food, Drug, and Cosmetic Act. Echoes from Past Warnings The disclaimers included on the website were likely derived from FDA commentary on previously submitted marketing pieces.

Branding 52

Branding Drugs Trials Marketing 52

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. That clause excludes those ingredients that were first marketed as drug ingredients.

Production 59

Production Marketing Drugs Licensing 59

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.

Marketing 52

Marketing Protein In-Vitro Production 52

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.

Sales 103

Sales Pharma Companies Branding Cosmetics 103

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

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.

Regulation 97

Regulation Research Production Cosmetics 97

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.

Protein 97

Protein Production Cosmetics Marketing 97

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

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 40

Cosmetics Marketing Production 40

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 Medicine Regulation Compliance 98

FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.

Regulation 114

Regulation Medicine Doctors Doctor 114

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

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

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 Manufacturing 52

XTalks

FEBRUARY 16, 2023

What Product is Seize the Night and Day Promoting? It’s also Indorsia’s first pharmaceutical product to be commercialized in the US. The global insomnia market was worth an estimated $5.1 In light of the market size for this indication, Quviviq’s initial sales numbers may seem underwhelming. billion in 2022.

FDA Approval 105

FDA Approval Sales Branding Drugs 105

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.

Production 52

Production Branding Cosmetics Marketing 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

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.

Branding 40

Branding Production Marketing Cosmetics 40

XTalks

OCTOBER 8, 2020

Markets are increasingly in need of advanced artificial intelligence, flexible IoT data acquisition, compliant data lakes, deep learning and other industrial-grade technologies. Related: AI Algorithm Qualification. This is a symbol of change, not a change of symbol. Aizon’s AI Consulting.

Manufacturing 98

Manufacturing Life Science Cosmetics Regulation 98

XTalks

APRIL 14, 2021

This process has been used in the food industry before, such as in cheese production, for example. Synthetic dyes are found in several food products, such as canned peas, candy and cake icing. They are also found in beverages such as sports drinks and beauty products such as mouthwash and shampoo.

Regulation 94

Regulation Production Branding Research 94

XTalks

APRIL 12, 2023

The conglomerate maintains that the baby powder is safe, despite allegations of company coverups since the 1970s, as well as unethical marketing practices targeting Black communities. The baby powder had multiple uses, including application to prevent diaper rash and for cosmetic uses, including dry shampoo.

Contamination 98

Contamination Cosmetics Production Sales 98

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

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.

Production 59

Production Marketing FDA Approval Cosmetics 59

Creogenic Pharma

MARCH 8, 2021

250+ Products. Top PCD Pharma Company provides their market with various products which are in high demand and regular use. The distributor or the channel partner of these companies takes care of the distribution, selling, advertising, and other market support. Distributor ? Wholesaler ? Get Started with. Lowest Price.

Pharma Companies 52

Pharma Companies Production Pharma Production Marketing 52

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

XTalks

APRIL 26, 2021

The Upcycled Food Association (UFA) recently introduced its certification marker to provide consumers with guidance about the presence of upcycled foods in a wide range of products. The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. Defining Upcycled Foods.

Packaging 59

Packaging Packaging Production Branding 59

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 FDA interprets “pattern” to refer to multiple, sequential, or repeated measurements of a signal or from a signal acquisition system. Criterion 2.

Development 105

Development Regulation Cosmetics Life Science 105

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. The app provides users with rebates on products they buy frequently. Ibotta’s business model is unique in the food industry.

Marketing 52

Marketing Branding Production Cosmetics 52

pharmaphorum

DECEMBER 9, 2021

I am fascinated by the breadth of my role, which encompasses self-care products, skin health, sustainability and much more. She has experience in R&D management of new product development, external innovation and OTC, cosmetic and commodity regulatory affairs. From the very beginning, I thought, ‘Right, I love this!

Allergies 105

Allergies Life Science Development Scientist 105