Newsletter | April 1, 2024

04.01.24 -- New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis



New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis

On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.


Spray Drying To Enable New Inhaled Drug Products

The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or a rapid onset therapeutic.

How A Flexible Approach To Autoinjector Assembly Can Be Advantageous

Examine how a flexible, scalable, and efficient solution for the assembly of autoinjectors can help you stay ahead of the competition and meet the demands of an ever-changing industry.

An Easy-To-Swallow Depression Drug For Elderly Patients

Discover an innovative formulation approach that helped a developer create a version of its drug that promotes treatment compliance within the geriatric population.

Developmental Testing Of IV Solutions

As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

Why KinetiSol Is Disrupting Spray Drying

Review a process not only capable of reproducing spray-dried dispersions with less complexity and environmental impact but also with the capability to out-design and outperform spray drying.

Evolution Of Novel Polymers To Overcome Limits In Sustained Drug Delivery

Degradable polymers evolved from aliphatic polyesters to nitrogen-bearing biomaterials such as polyurethanes and polyester amides. Explore a brief history of the development of PEA polymers.

Combining Gene Therapies, Carrier Systems, And Medical Devices

Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.


Excel IV: An Evolving Market Affirms The Value Of An Established Offering

Small, Simple-To-Use Package For Delivering High-Viscosity Formulations

Sterile Formulation Development