XTalks

APRIL 14, 2021

How Are Synthetic Food Dyes Regulated? The US Food and Drug Administration (FDA) defines color additives as “any substance that imparts color to a food, drug, cosmetic, or the human body. Meanwhile, in Europe, the regulations of synthetic dyes differ from those in the US. 40 and yellow food dyes no.

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Regulation Production Branding Research 94

pharmaphorum

OCTOBER 27, 2022

Companies are responsible for all content disseminated via a digital channel when the content is initiated, branded, and/or sponsored by the company or a third party acting on its behalf. Why is guidance needed? What are the key points from the Guidance? What are the rules on Social Media Influencers and Digital Opinion Leaders?

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Life Science Medicine Regulation Compliance 98

FDA Law Blog

DECEMBER 21, 2023

Those who attended their annual Enforcement, Litigation, and Compliance Conference holiday reception earlier this month got a sneak peek at this new branding effort with the unveiling of the association’s new logo ( here ). The new logo — and a host of other new association branding—will be rolling out throughout 2024.

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Branding Compliance Regulation Cosmetics 59

Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . billion, about 50% was dedicated to regulating medical products, including prescription drugs.

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Generic Drugs Manufacturing Drugs Regulation 68

XTalks

FEBRUARY 8, 2021

Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023.

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Production Insulin Branding Generic Drugs 78

XTalks

NOVEMBER 24, 2022

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. Other major brands like PepsiCo and Carl’s Jr. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. 331(ll) and 331(a).”.

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Production Branding Cosmetics Marketing 52

The Pharma Data

MARCH 15, 2022

To further facilitate generic drug development, and to assist the generic pharmaceutical industry in this process, the FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their brand name counterparts.

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FDA Approval Generic Drugs Production Drugs 52

The Pharma Data

NOVEMBER 10, 2020

coli O157:H7 strain found by Michigan Department of Agriculture and Rural Development (MDARD) in Tanimura & Antle brand packaged single head romaine lettuce. brand packaged single head romaine lettuce with a pack date of Oct. SILVER SPRING, Md. , coli O157:H7 illnesses that matches the E. SOURCE U.S. Food and Drug Administration.

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Contamination Packaging Packaging Production 52

FDA Law Blog

SEPTEMBER 15, 2022

It details FDA’s interpretation of the regulation 21 C.F.R. FDA interprets the regulation for drug products without an established name (generally monograph drug products do not have an established name) as requiring the name of the active ingredient, the pharmacological category, and strength. (The underline added).

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Drugs Production Regulation Containment 45

XTalks

SEPTEMBER 28, 2023

This is because the US has more lenient food ingredient regulations, potentially exposing consumers to carcinogens and harmful chemicals. Up until recently, popular fruit drinks from leading brands like Coca-Cola and PepsiCo, including Mountain Dew and Gatorade, contained BVO.

Hormones 52

Hormones Containment Production Cosmetics 52

The Pharma Data

MAY 27, 2022

On Tuesday, the FDA announced that it informed Kendal Nutricare that the agency is exercising enforcement discretion for the importation of certain infant formula under the Kendamil brand. store shelves beginning in June. Source link: [link].

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Production Manufacturing Pharmacy Cosmetics 52

The Pharma Data

NOVEMBER 26, 2020

We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. The record results achieved on November 25, 2020 were followed up by another very strong showing on Thanksgiving Day (November 26, 2020).

Life Science 52

Life Science Production Cosmetics Manufacturing 52

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

FDA Law Blog

JANUARY 1, 2025

This bill would go a long way to alleviating the concerns of the generic industry (AAM has applauded it), but it will clearly have objections from the brand side. The sponsors describe it as a safe harbor in a one-page explainer on the bill available here.

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Cosmetics Generic Drugs Branding Drugs 105

FDA Law Blog

JANUARY 9, 2025

As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company delays, denies, or limits an inspection, or refuses to permit an entry or inspection. FD&C Act 501(j).

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Regulation Manufacturing Drugs Branding 105

Pharmacy Checkers

JANUARY 4, 2020

The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. J(2) stipulates that the FDA can permit personal imports with specific waivers or by general regulation. Importation from Canada is legal under this section of U.S.

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Drugs Pharmacy Medicine Regulation 58

XTalks

MARCH 27, 2023

The extent of the FDA’s problems is reflective of all the different responsibilities the vast agency has, ranging from control and supervision of food safety and cosmetics to pharmaceutical drugs and medical devices. That means the FDA is requesting approximately 1.8 percent of its total budget for food safety. Part of the $128.2

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Cosmetics Regulation Contamination Drugs 98

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. J)(2) Waiver authority. for drug safety.

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Pharmacy Drugs FDA Approval Licensing 41

Pharmacy Checkers

AUGUST 2, 2019

These drugs, as explained below, are safe and effective foreign brand versions of the same drugs sold here. This recognition of equivalent brand drug safety is a step in the right direction. The first proposed channel of prescription drug importation is already codified in law: Section 804 of the Food, Drug and Cosmetic Act.

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Drugs FDA Approval Pharmacy Cosmetics 69