XTalks

JANUARY 5, 2024

Eli Lilly launched LillyDirect this week, an online service that provides access to the company’s medicines, including its newly approved weight loss drug Zepbound (tirzepatide). Interestingly, the company’s blockbuster diabetes drug, Mounjaro (tirzepatide), is not available through the new digital service.

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XTalks

NOVEMBER 17, 2022

She explains that ultra-processed foods contain more artificial ingredients than those that just have added salt, sugar or oil. They usually have very few whole ingredients and contain flavorings, colorings or other additives. The team wonders why Red 3 is allowed in food but not in cosmetics.

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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. the nanotube—is irrelevant, as it is the “active ingredient” that matters for purposes of classifying the product as a drug or biologic.

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The Pharma Data

NOVEMBER 29, 2021

Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery. The FDA, an agency within the U.S.

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FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S.

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FDA Law Blog

JULY 7, 2022

Livornese — Ten years in the making, a proposed rule was issued by FDA last week that has the potential to bring some prescription drugs that have not been able to gain an OTC approval to retail shelves at long last. To date, no OTC drug has been approved under this guidance.

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Advarra

JULY 26, 2022

However, it’s not legal federally and is considered a Schedule I drug by the U.S. Drug Enforcement Administration (DEA), meaning it has no accepted medical use and a high potential for abuse. Cannabis plants and derivatives containing no more than 0.3% Currently, cannabis use is legal across many states in the U.S.,

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

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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.

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

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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. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.

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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. Food and Drug Administration , No. A key to efficient drug development is transparency. 1:22-cv-0938 (D.D.C.

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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). They are banned because they contain non-edible items, posing a risk, particularly to children.

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XTalks

SEPTEMBER 28, 2023

One of the reasons behind this gap is the US Food and Drug Administration’s (FDA) “ generally recognized as safe ” — or GRAS — designation. The Environmental Working Group (EWG) identified several food products containing this chemical, such as Entenmann’s Coconut Crunch Donuts and Sara Lee Honey Glazed Buns.

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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.

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FDA Law Blog

APRIL 19, 2023

If that language sounds familiar, that’s because it is very similar to the language used to describe the process by which FDA determines that a new drug application (NDA) will be filed (or not). Reminders of the need to fulfill existing environmental assessment requirements and make all submissions electronically are also included.

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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.

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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.

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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.

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FDA Law Blog

OCTOBER 17, 2021

As part of the process of moving from the old rule-based monograph system to an administrative order framework, the CARES Act provides that in most cases a final monograph or tentative final monograph that establishes conditions of use for a drug described in section 505G(a)(1) or (2) of the FD&C Act is “deemed to be a final order”.

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FDA Law Blog

JUNE 28, 2023

ASCA was authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). For testing conducted under ASCA, the FDA will have confidence in the testing laboratories’ test methods and results and does not intend to request additional information regarding testing methodologies.

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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).

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FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). Do you really have to identify both “Grants” to be correct?

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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.

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The Pharma Data

DECEMBER 30, 2020

that may contain potentially fatal levels of aflatoxin. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Food and Drug Administration. SOURCE U.S.

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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.,

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The Pharma Data

FEBRUARY 18, 2022

Food and Drug Administration announced it is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections. Products that do not contain the information listed above are not impacted. Today, the U.S. As a result of the ongoing investigation, along with the U.S. and were likely exported to other countries.

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Advarra

JULY 19, 2022

If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Please discuss the transfer of investigational new drug (IND) sponsorship from one sponsor to another and that process. Q: Can you ship a drug from another country to the U.S. Q: What is the definition of a drug?

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FDA Law Blog

APRIL 21, 2024

Accordingly, had Taiho marketed the product with labeling containing those errors, that labeling would have been false. 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.,

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FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

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Pfizer

AUGUST 15, 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. Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID.

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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”). million and US$1.8 million. . Juyou Bio-Technology Co.,

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The Pharma Data

DECEMBER 4, 2021

Continuing to advance and launch much-needed generic drugs is critical to ensuring access to quality medicines to everyone who needs them.” You are encouraged to report side effects of prescription drugs to the FDA. “The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. About Teva.

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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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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.

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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”?

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Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

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