fbpx
September 1, 2022

Expanded Access (Compassionate Use) Submission Data Archive: CDRH

CDRH IDE Expanded Access Requests (2014-2016)1 Expanded Access Totals FY 2014 FY 2015 FY 2016 Requested Received 218 222 136 Evaluable Requests2 212 211 124 Approved […]
September 1, 2022

FDA initiates the Lysosomal Diseases Pre-Consortium at the Critical Path Institute

[9/1/2022] FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce its partnership with the Critical Path Institute (C-Path) to explore the feasibility of […]
August 31, 2022

FDA NanoDay Symposium 2022 – 10/11/2022

On This Page Date: October 11, 2022 Time: 8:50 AM – 3:10 PM ET Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]
August 30, 2022

Protecting the Public from Unapproved, Diverted, or Counterfeit Drugs presenting Overdose Risks

To enhance the security of the U.S. drug supply chain, FDA is: Preventing and reducing counterfeit and illegal online sales Instituting enhanced targeting and screening methods […]
August 30, 2022

Protecting Americans from Unapproved, Diverted, or Counterfeit Drugs presenting Serious Overdose Risks

To enhance the security of the U.S. drug supply chain, FDA is: Preventing and reducing counterfeit and illegal online sales Instituting enhanced targeting and screening methods […]
August 30, 2022

Advancing Evidence-Based Treatments

To expand therapy options, availability, and access, FDA is: Expanding availability and access to evidence-based treatments for substance use disorders Facilitating development of treatments for substance […]
August 30, 2022

Encouraging Harm Reduction

To reduce morbidity and mortality associated with overdoses, FDA is: Expanding availability and access to overdose reversal products, including naloxone, by supporting accelerated review of products […]
August 30, 2022

Supporting Primary Prevention

To eliminate unnecessary initial exposure and inappropriate prolonged prescribing of substances with abuse potential, FDA is: Promoting appropriate prescribing of medications with abuse potential, including opioids, […]
August 30, 2022

Safe Use Initiative

Today, tens of millions of people in the United States depend on prescription and OTC medications to sustain their health—more than four billion prescriptions are written […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0