US FDA Proposes Fee Increases for Certification Services on Color Additives
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
Japan’s MHLW Publishes New Quality Standards for Quasi-Drugs
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FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
Brazil’s Anvisa authorizes Remdesivir for Pediatric- Use in the treatment of Covid-19
Anvisa approved, on Monday (11/21), the extension of use of the antiviral drug Remdesivir for pediatric use in the treatment of Covid-19.
Brazil’s ANVISA Approves new Normative for the Registration of New and Innovative Medicines
On October 2022 Anvisa publishes approval measures for the registration of new and innovative medicines in Brazil
FDA-Advancing Real World Evidence Program
In 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.
Brazil’s ANVISA Announces Medical Device Registration 2022 Updates
ANVISA Brazil announced in early September 2022 important updates to its Collegiate Directorate Resolution (RDC) 185/2001.
The changes strengthen the country’s medical device registration regulations on the effective date of March 1, 2023.
US-FDA Publishes New Requirements for OTC Drugs Labeling
On September 8,2022, FDA published the draft of a guideline that provides recommendations on the labeling of OTC drugs.
FDA Approves Free Sale of OTC Hearing Aids
In August 2022, the FDA finalizes the historic rule allowing millions of Americans access to over-the-counter hearing aids.
FDA publishes product-specific guidances to facilitate generic drug development
FDA publishes product-specific guidance’s to facilitate generic drug development.
Overview of generic drug registration with USFDA
Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug.