‘PreCheck Program’ is a Direct Call to Manufacturers

Introduction

The U.S. Food and Drug Administration (FDA) is a centre for public health and well-being, a federal agency under the supervision of the Department of Health and Human Services. The agency is responsible for assessing the tolerability, efficacy, and safety of biological products, veterinary medicines, cosmetics, and medical devices, among other products. The agency holds the power and responsibility for approvals and rejection of drug development plans according to data presented by the healthcare companies.

Announcement

FDA introduced a new PreCheck Program to mainly connect with the manufacturers to guide them and give more time to them, noting any help, improvement or suggestion on the design to run the facilities smoothly. The FDA took this decision on the new program after learning of the Trump administration’s crazy and continued efforts to gear up the U.S.’s domestic drug supply chain. With the help of PreCheck, the agency will start to consider the applications to meet companies' needs regarding manufacturing in their respective regions.

A Bunch of Benefits to the Healthcare Companies

This new PreCheck program will have a golden opportunity to have a valuable conversation with the agency, as the agency is practising to give ample time to crucial scenarios involving facility rebuilding. Mainly, the most needed guidance on pre-production and site design will be provided to prevent any loss to the operational activities and money. Including additional guidance to applications regarding the Manufacturing, Controls and Chemistry sections. The FDA opened the application window for the eligible participants.

Process

After witnessing the wave of applications FDA decided to regulate batch-wise (facilities) based on application review, considering national priorities at first place. If the applications consist of crucial drug production for timely production and domestic need, along with the twist of innovation, then only it will be selected for the first batch as a first priority.

This year, in any month and time, this new program shall continue with its work because, as of now, the timeline and number of program participants to accept or enter are yet to be mentioned.

The contract researchers and manufacturers have eager eyes open for this new program, as this would help them to sign more partnership deals. PreCheck is cutting down the long feedback queue to stay tuned with the company during its construction process, just like a well-wisher performing and proving its role in the companies’ long term goal.