FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. 23-92-604(c)(1), (2) (Act 1103). & Mfrs.

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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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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 The draft guidance defines RRAs to include records requests under Section 704(a)(4).

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Pharmaceutical Technology

MAY 16, 2023

Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceutical manufacturer in Canada, for an undisclosed sum. The merged entity represents one of the biggest specialist generic injectable operations in Canada with local manufacturing facilities.

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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.”.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 21, 2022

Further, […].

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STAT News

MARCH 9, 2023

billion ask for the Food and Drug Administration, which includes funding specifically set aside for improving the oversight of food manufacturing, regulating cosmetics, and making the medical device supply chain more resilient. The request made Thursday also details a $7.2 Continue to STAT+ to read the full story…

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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.

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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., Source link: [link].

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FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.

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Pharma Tutor

FEBRUARY 2, 2023

The purpose of FDA inspections is to ensure the safety and efficacy of food, drugs, medical devices, and cosmetics, as well as to monitor their quality control systems and manufacturing practices.

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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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XTalks

MARCH 21, 2024

This effort also supports quality manufacturing across the pharmaceutical industry. An additional $8 million is allocated for the Modernization of Cosmetics Regulation Act (MoCRA), which aims to enhance cosmetic product safety. Modernization and Mission Support The FDA food budget proposes $114.8

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Pharma in Brief

NOVEMBER 20, 2023

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

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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.

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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.

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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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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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Drug Discovery World

NOVEMBER 30, 2023

The initial approvals of these products included postmarketing requirements (PMRs) under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies occurring after treatment.

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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 overview Merck, a subsidiary of E.

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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). FDA Publishes ICH Guidelines on Continuous Manufacturing. FDA Guidance Addresses Real-World Evidence Data Standards.

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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 overview Merck, a subsidiary of E.

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Gene Editing DNA Cosmetics Life Science 100

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. STX-241 and STX-721, both target EGFR mutations in non-small cell lung cancer (NSCLC).

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Roots Analysis

FEBRUARY 20, 2022

Role of nanoparticles has been well established across various markets, such as healthcare, paint, consumer products ( including sunscreens, cosmetics ), aerospace and glass industries. However, manufacturing of these particles is a major challenge for players engaged in the industry. Nanoparticles Contract Manufacturing.

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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. This integration provides a holistic view of product safety, from manufacturing through post-market surveillance.

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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.

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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.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).

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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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XTalks

OCTOBER 8, 2020

Aizon is well positioned to help those manufacturing sectors meet stringent regulatory requirements and extract deeper understanding of complex processes, which ultimately leads to new sources of value,” said John Vitalie, chief executive officer of Aizon, in the press statement from the company.

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XTalks

SEPTEMBER 17, 2020

The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. FDA Chief Counsel Stacy Amin said in a statement , “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk.

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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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Pharma in Brief

JANUARY 7, 2024

Section 804 Importation Programs On October 1, 2020, the FDA published a rule entitled Importation of Prescription Drugs (the US Importation Rule ) to implement Section 804 of the Food, Drug, and Cosmetic Act. Biologics, controlled substances, and certain other drugs are not eligible for importation.

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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.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).

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FDA Law Blog

DECEMBER 8, 2022

On the other hand, these products are not subject to food allergen labeling requirements: Pet foods, animal feeds, cosmetics, drugs, or household cleaning products; An ingredient derived from a major food allergen that does not contain protein (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

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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. 150+ Skin & Cosmetic Products. They offer pharma franchise to interested parties.

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FDA Law Blog

MAY 8, 2023

FDORA added section 515C, “Predetermined Change Control Plans for Devices” to the Federal Food, Drug, and Cosmetic (FD&C) Act. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

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XTalks

JUNE 5, 2023

During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. Novo Nordisk, the pharmaceutical manufacturer of Ozempic and Wegovy, is actively addressing these supply challenges.

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