US FDA releases 5 New Over the Counter (OTC) Monographs (final orders)
In May 2023, the U.S. Food and Drug Administration issued five more final orders completing the process of publishing different monographs as part of the over the counter (OTC) monograph reform under the Act CARES.
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.
US-FDA Over-The-Counter Monograph Drug User Fee Program (OMUFA)
On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022
The US-FDA Launches New Reportable Food Registry (RFP)
On January 5, 2022, The FDA published a new, interactive public data dashboard that allows anyone to view historical data from the Reportable Food Registry (RFR).
The US FDA deems final Order for Sunscreens
On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.
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.