HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

November 2020: Final guidance – Regulatory Considerations for Microneedling Products – to provide industry with clarity about how to determine whether a microneedling product meets the […]

On This Page Date: December 13, 2022 Time: 9:00 AM – 5:00 PM ET Center: CDER Location: Please note that due to the impact of this COVID-19 […]

Docket Number: FDA-2022-D-2301 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Aluminum toxicity in parenteral nutrition (PN) represents a major safety concern, necessitating […]

The Division of Medication Error Prevention and Analysis (DMEPA) and Division of Mitigation Assessment and Medication Error Surveillance (DMAMES) within FDA’s Center for Drug Evaluation and […]

On December 6, 2022, FDA issued a final guidance, Homeopathic Drug Products, that describes the agency’s approach to prioritizing regulatory actions for homeopathic products posing the greatest […]

On This Page Date: December 15, 2022 Time: 13:00-17:00 Central European Time | 7:00 AM-11:00 AM United States EST OBJECTIVES This meeting will be held in virtual format […]

Docket Number: FDA-2017-D-6580 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes how we intend […]

Background Since 2019, the FDA Compounding Quality Center of Excellence has conducted the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as […]