FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately.

Drugs 59

Drugs Drug Delivery Systems Regulation Production 59

Pharmaceutical Technology

OCTOBER 26, 2022

Nano-based delivery systems are on the rise, as they enable manufacturers to deliver therapeutic agents to specific targeted tissue in a more controlled manner. Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 Billion in 2021 and is expected to reach USD 102.4 Billion in 2030.

Manufacturing 130

Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

Roots Analysis

AUGUST 8, 2023

The phospholipid bilayers continuously surround the dispersing aqueous media and create a vesicular system in response to mechanical shaking or heating. 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.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs In-Vivo 52

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Behfar, senior scientist at VTT, in the news release.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Roots Analysis

FEBRUARY 18, 2022

Myeloid cells represent a group of cells containing granulocytes, monocytes, macrophages, mast cells and dendritic cells, which play a key role in innate immunity. In the past decade, more than 1,500 clinical trials have been registered for evaluating drug therapies targeting myeloid cells. Myeloid Cells Targeting Therapeutics Market.

Drug Delivery Systems 52

Drug Delivery Systems Immune Response Clinical Trials Clinical Trials 52

Roots Analysis

FEBRUARY 16, 2022

In earlier times, container closure integrity testing was not regarded as an essential step in the process of manufacturing. The company developing drug product through such an intense process, use to consider container closure system only for packaging of the product. [1]

Containment 52

Containment Packaging Packaging Drug Delivery Systems 52

Roots Analysis

MAY 24, 2024

In the dynamic landscape of the healthcare sector, the evolution of drug delivery systems plays a significant role in transforming the management of chronic diseases. They are generally used in combination with primary containers, such as prefilled syringes and cartridges.

Drug Delivery 40

Drug Delivery Containment Contamination Production 40

Roots Analysis

FEBRUARY 13, 2023

The production of such drug products requires skilled labor, stringent manufacturing protocols and specialized expertise. Additionally, they also require appropriate drug delivery systems to efficiently administer the intervention (in a manner that they can avoid degradation by cellular endonucleases).

Manufacturing 52

Manufacturing Drug Delivery Systems Genetic Engineering RNA 52

STAT News

NOVEMBER 3, 2022

As always, we hope your day is productive and meaningful. The companies allege Moderna’s vaccine uses their technology for a drug-delivery system without permission. Citing Our choice today is the ever-seasonal pumpkin spice, for those tracking this sort of thing. And please do keep in touch.

Vaccination 97

Vaccination Vaccine Drug Delivery Systems Sales 97

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

The Pharma Data

APRIL 27, 2021

Recently the company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration based on data from the Phase 3 GEMINI 1 and GEMINI 2 clinical studies. A Minipump Continuous Drug Infusion Dog Model System to Identify Candidate Drugs and Drug Delivery Rates for Intracameral IOP-lowering Implants.

Research 40

Research Drug Delivery Systems Drug Delivery Production 40

Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

Contamination 130

Contamination Manufacturing Containment Production 130