XTalks

SEPTEMBER 17, 2020

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. Fortune Food Product did not respond to Xtalks’ request for comment.

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Production Contamination Cosmetics Bacteria 98

FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. Instead, FDA issued a request for records pursuant to Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA). The draft guidance defines RRAs to include records requests under Section 704(a)(4).

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Manufacturing Cosmetics Drugs Production 52

Pharmaceutical Technology

SEPTEMBER 29, 2022

Holding a presence in the cosmetic dermatology sector, Curatio’s portfolio comprises more than over 50 brands that are commercialised in India. Curatio has built a commendable set of high market share brands in cosmetic and pediatric dermatology that we look forward to adding to our product offerings.”.

Dermatology 147

Dermatology Cosmetics Branding Scientist 147

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.

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Cosmetics Compliance Branding Manufacturing 130

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., Related Information.

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Manufacturing Contamination Cosmetics Regulation 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. What is an Interchangeable Biological Product? What is a Biosimilar?

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Production Insulin Branding Generic Drugs 78

Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements.

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Development Manufacturing Production Packaging 187

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

Drug Discovery World

NOVEMBER 30, 2023

Despite the investigation, the FDA has emphasised that the overall benefits of these products continue to outweigh their potential risks for their approved uses. The FDA has cautioned that patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies.

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Cosmetics Clinical Trials Clinical Trials Gene Therapy 64

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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Manufacturing Production Drugs FDA Compliance 59

XTalks

MARCH 21, 2024

This significant financial request is aimed at bolstering food safety and nutrition, alongside advancing medical product safety and strengthening public health initiatives. This initiative includes hiring additional investigators to manage inspectional needs stemming from recent disruptions and shortages in human food and medical products.

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Cosmetics Production Regulation Manufacturing 52

Fossil Remedies

OCTOBER 16, 2022

The next important consideration is a proper distribution channel from the manufacturer to end customers. 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. Manufacturing Drug License.

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Licensing Licensing Pharma Companies Cosmetics 52

Pharmaceutical Technology

JUNE 10, 2023

It was under development for gastric cancer,HER2+ breast cancer, thymic carcinoma and solid tumor Otsuka Pharmaceutical overview Otsuka Pharmaceutical (OPC), a subsidiary of Otsuka Holdings Co Ltd, is a manufacturer and supplier of pharmaceuticals, food products, clinical testing, and medical equipment.

Cosmetics 100

Cosmetics Clinical Trials Clinical Trials Drugs 100

Pharmaceutical Technology

JUNE 10, 2023

It was under development for gastric cancer,HER2+ breast cancer, thymic carcinoma and solid tumor Otsuka Pharmaceutical overview Otsuka Pharmaceutical (OPC), a subsidiary of Otsuka Holdings Co Ltd, is a manufacturer and supplier of pharmaceuticals, food products, clinical testing, and medical equipment.

Cosmetics 100

Cosmetics Clinical Trials Clinical Trials Drugs 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. Merck KG, is a science and technology company.

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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. Merck KG, is a science and technology company.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

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

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

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., products intended for medical purposes).

Manufacturing 98

Manufacturing Regulation Compliance Production 98

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.

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Pharma Production Pharma Companies Production Contract Manufacturing 81

FDA Law Blog

AUGUST 27, 2023

The Guidance specifically states that it is issuing the Guidance – applicable to trading partners including manufacturers, distributors, dispensers, and repackagers – to address industry “readiness” to comply with the DSCSA’s provisions. Drug manufacturers have had electronic systems in place since 2017.

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Packaging Packaging Production Manufacturing 52

XTalks

JUNE 5, 2023

GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. Novo Nordisk, the pharmaceutical manufacturer of Ozempic and Wegovy, is actively addressing these supply challenges. mg and 2.4 mg doses of Wegovy.

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FDA Approval Containment Drugs Pharmacy 98

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

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.

Cosmetics 98

Cosmetics Production Protein Scientist 98

FDA Law Blog

MARCH 29, 2023

While many states have had standing orders that allow for the dispensing of naloxone without an individual prescription, “harm reduction programs” that provide products and services to at-risk individuals still faced logistical difficulties in acquiring naloxone due to its prescription-only status which I discussed in this October 2022 blog post.

Pharmacy 105

Pharmacy Drugs Manufacturing Production 105

FDA Law Blog

DECEMBER 8, 2022

1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., lampreys); Bony fish (e.g., trout); and. Cartilaginous fish (e.g., shark, rays, and skates).

Genetic Engineering 59

Genetic Engineering Containment Cosmetics Protein 59

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., products intended for medical purposes).

Manufacturing 75

Manufacturing Regulation Compliance Production 75

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. About 500,000 additional cans of specialized medical formula manufactured by Danone’s Nutricia business will be headed to the U.S. Califf, M.D. “We

Production 52

Production Manufacturing Pharmacy Cosmetics 52

FDA Law Blog

JUNE 17, 2021

Under section 502(ff) of the Food, Drug, and Cosmetic Act, a drug that is manufactured at a facility for which required OMUFA fees have not been paid is deemed misbranded. As with the arrears lists for other user fee programs, (possible) embarrassment is not the only consequence that accompanies appearing on the Arrears List.

Cosmetics 52

Cosmetics Manufacturing Containment Drugs 52

Roots Analysis

AUGUST 15, 2023

These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products. Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells.

Protein 52

Protein In-Vitro Production Reagent 52

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.

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Cosmetics Marketing Containment Manufacturing 52

The Pharma Data

MAY 16, 2022

Food and Drug Administration is announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. of products manufactured here for export to foreign countries.

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Production Manufacturing Cosmetics Marketing 52

FDA Law Blog

MAY 23, 2023

the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement). The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Containment Contamination Compliance Manufacturing 45

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). In the 2020 fiscal year, CBP seized 93,590 units of e-cigarettes that did not meet US federal regulations.

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Production Cosmetics Marketing Branding 98

The Pharma Data

MAY 27, 2022

Some of this product is currently in stock for transport and additional product is being produced in the coming weeks and months. Department of Health and Human Services is evaluating options for getting the products to the U.S. The company has information about the products and where to find product once in the U.S.

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Production Manufacturing Cosmetics Allergies 52

FDA Law Blog

JULY 13, 2021

With the approach of the January 1, 2022 mandatory compliance deadline for the BE standard, manufacturers and importers of food and dietary supplements should work to develop strategies for compliance and evaluating each product’s bioengineered (BE) status if they have not already done so.

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