XTalks

NOVEMBER 14, 2022

In the US, it’s against the law to use the carcinogenic color additive Red 3 in cosmetics, such as lipsticks or blush or topicals. As a result, in 1990, the agency eliminated certain “provisionally listed” uses of the chemical — meaning cosmetics and externally applied drugs. But those steps were never taken.

Scientist 98

Scientist Cosmetics Containment Drugs 98

Camargo

AUGUST 22, 2021

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. The FDA published three binding guidance documents regarding the TRC. Validation Code.

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Containment Bioavailability Cosmetics Packaging 190

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). 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.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

FDA Law Blog

DECEMBER 8, 2022

Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g.,

Genetic Engineering 59

Genetic Engineering Containment Cosmetics Protein 59

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). The guidance also contains some useful information, despite the limitations described above.

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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.

Cosmetics 52

Cosmetics Marketing Containment Manufacturing 52

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

Development 161

Development Production Immune Response Licensing 161

Advarra

JULY 26, 2022

Cannabis plants and derivatives containing no more than 0.3% Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.

Regulation 97

Regulation Research Production Cosmetics 97

XTalks

JULY 26, 2023

The first food products containing Brevel’s protein are scheduled to hit the market by 2024. The natural resource is harnessed as an alternative to fossil fuels, with application in cosmetics, pharmaceuticals and of course, as a source of food. However, Brevel isn’t the only company using microalgae for food products.

Protein 97

Protein Production Cosmetics Marketing 97

FDA Law Blog

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

Protein 95

Protein Production Regulation Cosmetics 95

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. The list includes several hundred facilities running over 70 pages.

Cosmetics 52

Cosmetics Manufacturing Containment Drugs 52

FDA Law Blog

JULY 13, 2021

The mandatory disclosure requirement of the BE standard applies to human food, including dietary supplements, that is subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act, as well as some products under the jurisdiction of the USDA’s Food Safety and Inspection Service.

Compliance 52

Compliance Regulation Cosmetics Manufacturing 52

FDA Law Blog

MAY 6, 2024

The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C). Once finalized, the content from the draft guidance will be included within the existing cybersecurity premarket guidance.

Manufacturing 105

Manufacturing Cosmetics Regulation Containment 105

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.

Containment 45

Containment Contamination Manufacturing Compliance 45

FDA Law Blog

AUGUST 19, 2021

The addition of “gluten-containing grain” when referencing food allergens, and the addition of “gluten-containing grain” to FSMA’s Hazard Analysis and Preventive Controls, as well as to food allergen inspections language. Defining the term “natural.”. A study on the fortification of corn masa flour.

Regulation 52

Regulation Containment Cosmetics Packaging 52

XTalks

SEPTEMBER 28, 2023

Parabens, which are also prevalent in cosmetics, can interfere with the regular operation of human hormonal systems, affecting both male and female reproductive health, development, fertility and birth results. Citrus-flavored beverages are particularly prone to containing BVO. BVO tends to accumulate in the human body.

Hormones 52

Hormones Containment Production Cosmetics 52

FDA Law Blog

APRIL 12, 2022

This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act. Torrente — On March 28, 2022, FDA transmitted its justification to Congress for its Fiscal Year 2023 budget.

Cosmetics 52

Cosmetics Drugs Containment Development 52

FDA Law Blog

JUNE 28, 2023

ASCA was authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 2022 Device Submissions with ASCA Testing According to the ASCA 2022 Annual Report , the “FDA received five submissions that contain ASCA testing: four with basic safety and essential performance testing and one with biocompatibility testing.

Containment 52

Containment Radiology Cosmetics Manufacturing 52

XTalks

APRIL 14, 2021

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. 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

FDA Law Blog

OCTOBER 17, 2021

Perhaps one day those numbers will be as familiar as references to the various parts of the CFR containing the monographs (maybe). We here at HPM hope that FDA will continue to maintain the webpage Status of OTC Rulemakings which contains easily accessed historical information and links. For each OTC monograph title (e.g.,

Containment 52

Containment Drugs Production Medicine 52

XTalks

APRIL 26, 2021

The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. From the images on its website , it appears as though there is a regular marker and one that informs consumers that the product contains minimal upcycled content, or less than ten percent.

Packaging 59

Packaging Packaging Production Branding 59

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. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. 331(ll) and 331(a).”.

Production 52

Production Branding Cosmetics Marketing 52

FDA Law Blog

JULY 4, 2023

After FDA issues a final order under Section 505G of the Food, Drug, and Cosmetic Act, requestors who will be subject to the final order and sponsors of OTC monograph drugs that will be subject to the final order are eligible to request formal dispute resolution.

Drugs 52

Drugs Cosmetics Containment Development 52

FDA Law Blog

APRIL 19, 2023

Module 5 should also include information about safe nonprescription marketing and use if the proposed drug contains an active ingredient not previously contained in certain OTC monographs or orders, and any postmarketing safety information.

Containment 59

Containment Drugs Cosmetics Marketing 59

FDA Law Blog

APRIL 25, 2023

A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” By Philip Won & Jeffrey K. Shapiro — Does your firm manufacture a “cyber device”?

Regulation 105

Regulation Cosmetics Production Manufacturing 105

FDA Law Blog

MAY 3, 2023

The initial group posted also included the administrative order containing a list of certain active ingredients offered for certain OTC uses FDA had found to be non-monograph conditions (former 21 CFR § 310.545).

Regulation 59

Regulation Containment Drugs Production 59

FDA Law Blog

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. DASCA became law, amending the CSA, on December 18, 2014.

Hormones 52

Hormones Drugs Manufacturing Regulation 52

XTalks

JANUARY 5, 2024

Along with the launch of LillyDirect this week, Lilly also issued an open letter recommending that Zepbound and Mounjaro not be used for “cosmetic weight loss.” An independent tool is available for patients to locate and connect with healthcare professionals nearby for in-person care if they prefer.

Drugs 59

Drugs Pharmacy Cosmetics Medicine 59

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.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

The Pharma Data

DECEMBER 4, 2021

Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes. Avoid applying Adapalene and Benzoyl Peroxide gel to cuts, abrasions, and sunburned skin.

Doctors 52

Doctors Doctor Medicine Production 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

FDA Law Blog

SEPTEMBER 17, 2024

OPDP alleges in this latest letter that the DTC TV ad made false or misleading representations and suggestions about the efficacy of UBRELVY, which is considered misbranding of the product under the Federal Food, Drug, and Cosmetic Act. Another point of interest is contained in footnote 6. Advantage, OPDP.

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Clinical Trials Clinical Trials Drugs Trials 59

FDA Law Blog

NOVEMBER 9, 2021

115-521 ) amended Section 745(A)(b) for the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include that after publication of a final guidance, pre-submissions and 510(k)s “shall be submitted solely in such electronic format as specified by the Secretary in such guidance.” Draft Guidance at 8.

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Containment Cosmetics Packaging Packaging 40

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. Customers complete an online consultation and receive a personalized prescription cream containing active ingredients tailored to their needs.

Branding 40

Branding Production Marketing Cosmetics 40

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). For additional information, please visit www.crescitatherapeutics.com.

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Licensing Licensing Dermatology Production 40

FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Clinical Trials Clinical Trials Trials Drugs 64