On January 2023, The U.S. Food and Drug Administration (FDA) published Radiological Health Regulations for Recording and Reporting Radiation Emitting Electronic Products and Performance Standards for X-ray, Laser and Ultrasonic Diagnostic Products.
On January 2023, The U.S. Food and Drug Administration (FDA) has issued a proposed rule to amend color additive regulations to increase fees for certification services. ves
On October 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) has published new quality standards and specifications of 2,647 ingredients and additives that can used in Quasi-drugs.
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
The FDA publishes updated Definitions of Face‑to‑Face Formal Meetings.
On October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program
China’s NMPA Announces they will Start Electronic system for Drug related Registration Certificates (2022)
China’s NMPA Announces they will start on Issuance of Drug Electronic Registration Certificates starting November 1st, 2022. China’s National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as legally valid as the paper version.
In August 2022, the FDA finalizes the historic rule allowing millions of Americans access to over-the-counter hearing aids.
On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022
In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products. The foreign manufacturers of APIs can apply for DMF registration.
Overview: On February 1st, 2022, the US Food and Drug Administration (FDA) issued a draft of guidance on formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency.The guidance clarifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, content of meeting requests […]
On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.