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 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.
THE US-FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain
FDA published FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain.
THE US-FDA publishes product-specific guidances (PSGs) to facilitate generic drug development
On May 2022, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product
The US FDA Announces OTC Monograph Drug User Fee Rates for FY2021
On December 28, 2020 , the U.S. Food and Drug Administration ( FDA) announced the rates for over the counter (OTC) monograph drug user fees for fiscal year (FY) 2021.
China’s NMPA resolves issues regarding current administration on drug distribution
NMPA announces a new revised Drug Administration Law of the People’s Republic of China effective since Dec 1, 2019.
Mexico’s COFEPRIS establishes new electronic Appointment System
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.
Mexico’s COFEPRIS promotes the production of generic drugs with new operating rules
COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.
The FDA publishes FY 2019 GDUFA Science and Research Report
The FDA’s FY 2019 GDUFA report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts.
Anvisa’s Call Notice 2/2020 : Similar Drug Notice
On Thursday (1/30), Anvisa published Call Notice 2/2020 , aimed at requesting information on similar drugs registered in Brazil.
Accelerated Approval of Detection Reagents of Coronavirus in China
The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.