Soli Deo Gloria

23/06/2024

07/05/2024

Are you struggling with the complicated process of filing a food and drug application? Let us help you navigate through the requirements and streamline the process.

07/05/2024

Why FDA Approval is Critical for Food and Drug Products?

Food and drug products must undergo strict review and approval by the FDA to ensure they are safe for consumption.

Learn why the FDA's seal of approval is essential for ensuring the safety of food and drug products.

***FDA Advisory No.2024-0748 || Pilot Implementation of the Electronic Certificate of Product Registration (E-CPR) Information System for the Application for Initial Registration of Generic Prescription Drugs for Human Use from 07 May 2024 to 07 August 2024***

The Food and Drug Administration (FDA) has developed the Electronic Certificate of Product Registration (e-CPR) Information System, which shall be included in the FDA eServices Portal System and shall serve as the platform for end-to-end processing of applications for initial registration of generic prescription drugs for human use. It integrates streamlined procedures, automated tracking of application status, and release of electronic communications and authorizations to applicants into one system.

Read more:->https://bit.ly/44tfNNL

30/04/2024

The Food and Drug Administration (FDA) Launches Task Force Diomede to Focus on Streamlining the Process of Classification of Borderline Health Products
The Food and Drug Administration (FDA) regulates several health products falling under the definitions of drugs, devices, cosmetics, household/urban hazardous substances, and food. Due to the development of an increased variety of health products, the Agency has encountered health products that share similar characteristics or are considered “borderline” between the different product categories.
In pursuit of the Agency’s mandate to protect public health through appropriate health product regulation, FDA Director General Dr. Samuel A. Zacate has launched Task Force Diomede.
Task Force Diomede aims to focus on streamlining the process of classification of borderline health products. An FDA Circular is currently being finalized by the Task Force so that the industry stakeholders shall be guided in the determination of the categories of health products prior to application for product registration.

The Food and Drug Administration (FDA) Launches Task Force Diomede to Focus on Streamlining the Process of Classification of Borderline Health Products

The Food and Drug Administration (FDA) regulates several health products falling under the definitions of drugs, devices, cosmetics, household/urban hazardous substances, and food. Due to the development of an increased variety of health products, the Agency has encountered health products that share similar characteristics or are considered “borderline” between the different product categories.

In pursuit of the Agency’s mandate to protect public health through appropriate health product regulation, FDA Director General Dr. Samuel A. Zacate has launched Task Force Diomede.

Task Force Diomede aims to focus on streamlining the process of classification of borderline health products. An FDA Circular is currently being finalized by the Task Force so that the industry stakeholders shall be guided in the determination of the categories of health products prior to application for product registration.

30/04/2024

***FDA Advisory No.2024-0154-A***
The Food and Drug Administration (FDA) informs the public that the food product CAFFE BENE Honey Grapefruit Ade Iced Drink is registered by the Market Authorization Holder (MAH) PHIL ACE VANTAGE INTERNATIONAL TRADING CORPORATION, in accordance to existing FDA rules and regulations.
Accordingly, the list released in FDA Advisory No. 2024-0154 is hereby updated to remove the aforementioned food product.
Read more:-> https://bit.ly/3UzENiW

***FDA Advisory No.2024-0154-A***

The Food and Drug Administration (FDA) informs the public that the food product CAFFE BENE Honey Grapefruit Ade Iced Drink is registered by the Market Authorization Holder (MAH) PHIL ACE VANTAGE INTERNATIONAL TRADING CORPORATION, in accordance to existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2024-0154 is hereby updated to remove the aforementioned food product.

Read more:-> https://bit.ly/3UzENiW

30/04/2024

***Draft for Comments || Prescribing the Guidelines on Good Manufacturing Practice (GMP) for Drug Manufacturers Repealing AO No. 2013-0022***

***Draft for Comments || Prescribing the Guidelines on Good Manufacturing Practice (GMP) for Drug Manufacturers Repealing AO No. 2013-0022***

The Food and Drug Administration through the Policy and Planning Service is hereby posting the attached proposed Administrative Order titled, “Prescribing the Guidelines on Good Manufacturing Practice (GMP) for Drug Manufacturers Repealing AO No. 2013-0022” for comments.

Read more:->https://bit.ly/3VtfRdW