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

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

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). 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. mg and 2.4 mg doses of Wegovy.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

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1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., All packaged foods served or sold on transportation carriers (e.g.,

Genetic Engineering 59

Genetic Engineering Containment Cosmetics Protein 59

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

The Pharma Data

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). Today, the U.S. Solomon, D.V.M.,

Genomics 52

Genomics Genome Production Marketing 52

Advarra

JULY 26, 2022

In order to understand the current status on cannabis and CBD research studies, it’s important to understand where each product stands. Cannabis plants and derivatives containing no more than 0.3% With the exception of one highly purified form of CBD (Epidiolex), no other CBD products are currently FDA approved.

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

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

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

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

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

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

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. Given that this is the first year the fees have been assessed, it is not surprising that the list is long.

Cosmetics 52

Cosmetics Manufacturing Containment Drugs 52

The Pharma Data

DECEMBER 30, 2020

.” Additional Information: The FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products manufactured by Midwestern Pet Foods, Inc. that may contain potentially fatal levels of aflatoxin. This is an ongoing investigation.

Production 52

Production Cosmetics Compliance Containment 52

XTalks

SEPTEMBER 28, 2023

This meant manufacturers could skip the FDA’s exhaustive safety review process, ensuring their products reached the market faster. Companies use the GRAS designation as a shortcut, introducing thousands of additives — some with known and unknown health risks — into American food products.

Hormones 52

Hormones Containment Production Cosmetics 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

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

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. Interestingly, this provision also applies to the terms “froot” and “frooty.”. Defining the term “natural.”.

Regulation 52

Regulation Containment Cosmetics Packaging 52

FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

The Pharma Data

APRIL 27, 2022

In particular, Action Levels for Lead in Juice: Draft Guidance for Industry , provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice. Source link: [link].

Cosmetics 52

Cosmetics Production Containment Contamination 52

XTalks

NOVEMBER 28, 2023

In the US, the regulation of food products, including the ban on certain items, falls primarily under the jurisdiction of two key agencies: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). The USDA, on the other hand, oversees the safety of meat, poultry and egg products, among other responsibilities.

Sales 52

Sales Regulation Containment Production 52

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).

Clinical Trials 64

Clinical Trials Clinical Trials Trials Drugs 64

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.” Therefore, a firm should first determine whether its product meets the statutory definition of a medical device. By Philip Won & Jeffrey K.

Regulation 105

Regulation Cosmetics Production Manufacturing 105

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Herbal Products: St. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

FDA Approval 52

FDA Approval Generic Drugs Production 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. Such systems provide control over the components used for the synthesis of target products making it easier to manipulate the contents according to specific needs.

Protein 52

Protein In-Vitro Production Reagent 52

The Pharma Data

FEBRUARY 18, 2022

Centers for Disease Control and Prevention and state and local partners, the FDA is alerting consumers to avoid purchasing or using certain powdered infant formula products produced at this facility. This is an ongoing investigation, and the firm is working with the FDA to initiate a voluntary recall of the potentially affected product.

Production 40

Production Bacteria Containment Cosmetics 40

The Pharma Data

NOVEMBER 29, 2021

The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Approval 52

FDA Approval Drugs Protein Cosmetics 52

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

FDA Law Blog

OCTOBER 17, 2021

nighttime sleep aid drug products), the repository provides an OTC Monograph ID (e.g., Perhaps one day those numbers will be as familiar as references to the various parts of the CFR containing the monographs (maybe). The deemed final order establishes the current monograph for OTC sunscreen products. M002) and an Order ID (e.g.,

Containment 52

Containment Drugs Production Medicine 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. According to Roots Analysis, natural skincare products currently capture around USD 17 billion of the global skincare market.

Branding 40

Branding Production Marketing Cosmetics 40

FDA Law Blog

SEPTEMBER 15, 2022

Draft Guidance Regarding the Statement of Identity and Strength for Human Nonprescription Drug Products. FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products.

Drugs 45

Drugs Production Regulation Containment 45

FDA Law Blog

JULY 26, 2022

Like all Guidance documents, it starts out with background, explaining that the Orange Book is FDA’s list of drug products approved under the Federal Food, Drug, and Cosmetic Act and contains patent and exclusivity information related to such products.

Production 52

Production Sales Drugs Cosmetics 52

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

The Pharma Data

DECEMBER 4, 2021

.” With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. is filled with a Teva generic product. Source link: [link].

Doctor 52

Doctor Doctors Medicine 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