FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. By Sophia R. Gaulkin — Last week, the U.S.

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. Importantly, as an octapeptide, Somatuiline Depot is a “protein” but consists of only eight amino acids linked in a polypeptide chain.

Protein 95

Protein Production Regulation Cosmetics 95

Roots Analysis

AUGUST 8, 2023

The hydrophobic portion contains two fatty acid chains with 10-24 carbon atoms, while the hydrophilic part primarily consists of phosphoric acid linked to a water-soluble molecule. Therapeutic Applications of Liposomes in Drug Delivery In comparison to existing formulations, liposomes offer greater therapeutic efficacy and safety.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs In-Vivo 52

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.

FDA Approval 52

FDA Approval Drugs Cosmetics Protein 52

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.

Hormones 52

Hormones Containment Production Cosmetics 52

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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Drugs Licensing Licensing Containment 69

Pfizer

AUGUST 15, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. 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.

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Drugs Vaccination Vaccine In-Vitro 99