FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
Anvisa approves release of vaccine and medicine against monkey pox
Anvisa approves release of vaccine and medicine against monkey pox
Registration of Generic & Comparative Drugs in Brazil
Before reaching the Brazilian consumer market, it is necessary that a drug has its quality, safety, and therapeutic efficacy evaluated by the National Health Surveillance Agency (ANVISA).
Brazil’s Fiocruz concludes genetic sequencing of monkeypox virus detected in Rio de Janeiro
Fiocruz, through its Genomics Network, has concluded the genetic sequencing of the monkeypox virus (MPXV) collected from a sample coming from Rio de Janeiro.
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
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 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THE US-FDA Announces Draft Guidance on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On May 5th, 2022, the FDA announced the availability of a draft guidance for industry entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies.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