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

Roots Analysis

AUGUST 15, 2023

Biomanufacturing utilizing cell free systems is an emerging area of research that enables the synthesis of different biomolecules, such as cytotoxic proteins, fusion proteins, post translationally modified proteins, antibodies, enzymes, vaccines and other complex proteins, without the use of living cells.

Protein 52

Protein In-Vitro Production Reagent 52

XTalks

AUGUST 2, 2023

It contains the antiviral medications nirmatrelvir and ritonavir. 2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. Pfizer’s total global revenue from Paxlovid was $18.93 billion in 2022.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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. Other applications of liposomes include the encapsulation of food and cosmetic materials, along with routine chemical analysis.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs In-Vivo 52

Roots Analysis

SEPTEMBER 9, 2024

The rising demand for protein therapeutics, such as monoclonal antibodies and vaccines , is driving advancements in protein expression technology to ensure efficient and scalable production. Prokaryotic Expression System: This expression system is used in structural analysis, antibody generation and functional assays.

Protein 40

Protein Gene Production DNA 40

FDA Law Blog

FEBRUARY 29, 2024

From there, the PTO notes that a PTE “determination is made based on the representations contained in the PTE application,” and that “35 U.S.C. § As part of the Accelerated Approval, Oncopeptides was required to conduct “further adequate and well-controlled clinical trials to verify and describe clinical benefit.” That did not happen.

Production 59

Production Drugs FDA Approval Compliance 59

FDA Law Blog

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. 1, 2023, sesame.

Cosmetics 105

Cosmetics Allergies Production Containment 105