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.
Brazil’s Anvisa outlines Pharmaceutical Registration Exceptions due to COVID-19
Anvisa has published a Resolution RDC Nº 392 2020, that defines the criteria for the application of exceptions to Good Manufacturing Practices and Import requirements for drugs and pharmaceutical during COVID-19.
The Newly Enacted CARES Act reforms the FDA OTC Monograph Process
The United States Food and Drug Administration reforms the Over the Counter (OTC) process under the CARES Act signed by Congress in March ’20 to provide emergency relief affected by the COVID-19 pandemic.