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 For additional information, please visit www.crescitatherapeutics.com.
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.
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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.
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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). exclusively licensed U.S. How, pray tell, does this relate to PTEs you ask?
Druggist
OCTOBER 25, 2020
Calamine lotion available in the UK for management of chickenpox symptoms contain a mixture of calamine (15%) and zinc oxide (5%). Nevertheless, calamine lotion is licensed in the UK for symptomatic relief of skin conditions including itchiness. Creams contain higher amounts of oil(s), and therefore are of thicker consistency.
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).
Advarra
JULY 19, 2022
A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim.
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