The US- FDA Launches New Accelerating Rare disease Cures (ARC) Program
On May 2022, the US-FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the new Accelerating Rare disease Cures (ARC) Program.
THE US-FDA Announces Draft Guidance on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On May 5th, 2022, the FDA announced the availability of a draft guidance for industry entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies.
The USA FDA updated Electric CPP’s with quick response QR code
Beginning on March 25, 2022, the FDA will be adding a unique quick response (QR) code to electronic Certificates of Pharmaceutical Products (eCPPs)
FDA REMINDS HAND SANITIZER MANUFACTURERS THEY CAN NO LONGER DISTRIBUTE WITH TEMPORARY POLICIES AFTER MARCH 31, 2022
FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA’s temporary policies (withdrawn on December 31, 2021), they must stop distribution of any remaining hand sanitizer produced consistent with the temporary policies by March 31, 2022.
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 USA FDA Issues Guidance on Enforcement Discretion Policies for Certain FSMA Regulations
On March 11, 2022, the U.S. Food and Drug Administration (FDA) issued guidance on its intent not to enforce certain provisions of five rules that implement the FDA Food Safety Modernization Act (FSMA).
Brazil’s Anvisa and FDA Renew Declaration of Technical Cooperation
On March 8, 2022 Brazil’s Anvisa and the U.S. Food and Drug Administration (FDA) have signed a Cooperation Statement aimed at maintaining and strengthening their collaboration mechanisms.
South korea’s MFDS announces revision of Standards and Specifications for Health Functional Food on functional ingredients
The revision strengthens safety management standards for 8 functional ingredients.